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Lead Magnet Portal/Website by American Ratings – Boost Credibility, Acquire Clients, and Grow Your Business

In today’s competitive business environment, credibility, trust, and client engagement are key to sustainable growth. Lead Magnet Portal/Websiteis a revolutionary platform designed to help businesses and professionals enhance their reputation and expand their reach through the globally recognized A-I-R-S (American Industry Ratings Standard) Number.

Lead Magnet Portal/Website by American Ratings primarily provides Business and Individual American A-I-R-S Numbers, usable by citizens or businesses from any country.

The primary usage of Lead Magnet Portal/Website by American Ratings is to:

Acquire new clients

Retain existing clients

Verify vendors

Generate revenue by purchasing A-I-R-S Number points wholesale and selling to the general public or businesses in retail

Whether you are a Gen Z professional, senior executive, small business owner, or large corporate, LeadMagnet is suitable for all industries and professional levels.

What is LeadMagnet?

Lead Magnet Portal/Website is a digital portal by American Ratings that allows businesses and professionals to obtain and distribute A-I-R-S Numbers, which act as a verified digital badge of credibility.

The platform uses a points system:

1 Individual A-I-R-S Number = 1 point

1 Business A-I-R-S Number = 5 points

Cost per point = $50

It is ideal for creating reward systems, vendor management, and reselling A-I-R-S Numbers, making it highly versatile for businesses, professionals, and even financial advisors like CAs and CPAs.

Key Features of Lead Magnet Portal/Website by American Ratings

Global Recognition: Credibility in over 150 countries

Client Acquisition & Retention: Attract and maintain a loyal customer base

Vendor Verification: Quickly verify vendors, partners, and affiliates

Revenue Generation: Purchase points wholesale and sell A-I-R-S Numbers in retail

Universal Access: Suitable for all businesses and professionals, small to large

Reward & Vendor Management: Use the portal as a reward or vendor management system

Benefits of Using Lead Magnet Portal/Website by American Ratings

Enhanced Credibility: Verified A-I-R-S Numbers increase trust

Higher Engagement & Conversion: Verified profiles boost client confidence

Flexible Monetization: Businesses can generate revenue by reselling points

Scalable Solution: Grow your business as your points system expands

Comprehensive Use Case: Supports client acquisition, retention, vendor verification, and rewards

How to Get Started

Sign Up: Create an account on the Lead Magnet Portal/Website

Purchase Points: Buy the required number of points at $50 per point

Assign or Resell: Distribute to clients, employees, or resell in retail

Track Results: Monitor engagement, vendor verification, and revenue impact

Why Choose Lead Magnet Portal/Website by American Ratings?

Unlike traditional rewards or verification methods, Lead Magnet Portal/Website by American Ratings provides a verified digital identity that strengthens relationships, builds trust, and generates revenue. Businesses and professionals from all industries Gen Z to senior executives, small businesses to large corporates can leverage LeadMagnet to grow credibility and business impact worldwide.

Call to Action

Get Started Today: Sign Up onLead Magnet Portal/Website Purchase A-I-R-S Points: Secure your credibility and start growing your client base

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XPRO America – US FDA Drug Establishment Registration (21 CFR Part 207)

The US FDA Drug Establishment Registration is a mandatory requirement under 21 CFR Part 207 for all facilities engaged in the manufacturing, repacking, relabeling, or distribution of human and veterinary drugs intended for the U.S. market. This regulation applies to both domestic and foreign facilities, ensuring that all establishments involved in the drug supply chain are properly registered with the FDA.

The registration process is crucial because it allows the FDA to monitor drug safety, trace supply chains, and enforce compliance with federal drug laws. Without proper registration, facilities risk import refusals, warning letters, product recalls, and enforcement actions that can disrupt business operations.

Drug Establishment Registration must be completed electronically through the FDA’s Electronic Submissions Gateway (ESG)using Structured Product Labeling (SPL) format. In addition, each registered establishment is assigned an FDA Establishment Identifier (FEI) number, which is used to track regulatory compliance and inspections.

Key requirements under 21 CFR Part 207 include:

Initial Establishment Registration for facilities manufacturing, repacking, relabeling, or distributing drugs.

Biennial Renewal of registration, which must be completed between October 1 and December 31 of each even-numbered year.

Drug Listing Submissions for every drug product intended for U.S. commercial distribution.

Compliance with cGMP (Current Good Manufacturing Practices) to ensure product safety and quality.

At XPRO America, we simplify the complex FDA registration process for pharmaceutical manufacturers and distributors worldwide. Our services include:

Assistance with ESG account setup and SPL preparation.

Complete facility registration and product listing support.

Guidance on compliance with 21 CFR Part 207 requirements.

Ongoing monitoring to ensure timely biennial renewals and regulatory updates.

By partnering with XPRO America, companies gain confidence that their FDA Drug Establishment Registration is accurate, compliant, and completed on time ensuring uninterrupted access to the U.S. pharmaceutical market.

XPRO America helps with US FDA Drug Establishment Registration (21 CFR Part 207), ESG submissions, and biennial renewals for pharmaceutical facilities.

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FDA Product Recall & Enforcement Guidance – XPRO AMERICA

In the highly regulated U.S. market, product recalls and enforcement actions can significantly impact a company’s reputation, finances, and consumer trust. Whether involving food, dietary supplements, cosmetics, or medical devices, recalls are often initiated due to safety concerns, mislabeling, contamination, or non-compliance with FDA regulations. Having a proactiverecall and enforcement strategy is essential for minimizing risks and ensuring swift, compliant responses when issues arise.

The FDA requires companies to be prepared with a recall strategy development planthat details how a product withdrawal will be managed, including notification of distributors, sretailers, and consumers. A strong recall plan outlines responsibilities, communication protocols, product traceability systems, and corrective actions to prevent recurrence. Without such a strategy, businesses may face regulatory delays, consumer backlash, and increased legal liabilities.

When a recall or enforcement action occurs, effectiveliaison with the FDA is critical. Companies must communicate openly with the agency, provide accurate documentation, and demonstrate corrective measures. The FDA closely monitors recall effectiveness and may escalate enforcement actions—such as warning letters, import alerts, or product seizures—if a company fails to comply. Having regulatory experts manage these communications ensures timely responses and reduces the risk of escalation.

Beyond recalls, FDA enforcement can take many forms, including inspections, 483 observations, injunctions, and facility registration suspensions. Businesses that lack proper compliance systems are more vulnerable to these actions. Proactive readiness through audits, quality controls, and labeling reviews reduces the likelihood of enforcement and protects market continuity.

At XPRO America, we help companies develop customized recall strategies, implement traceability systems, and serve as regulatory liaisons during enforcement actions. Our team guides businesses in preparing documentation, managing communications with the FDA, and executing corrective action plans. With expert support, companies can navigate recalls efficiently, protect consumer trust, and restore market confidence.

A well-prepared recall and enforcement plan is not only a regulatory requirement it is a safeguard for your brand and your customers.

XPRO America supports FDA product recalls with strategy development, traceability systems, and liaison services during enforcement actions to protect your brand.

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XPRO America – FDA Post-Market Reporting & Pharmacovigilance Support

Pharmaceutical companies must ensure the safety and effectiveness of their products even after FDA approval and U.S. market entry. This ongoing responsibility is managed through post-market reporting and pharmacovigilance programs, which play a critical role in identifying, assessing, and mitigating potential risks associated with human and veterinary drugs.

The U.S. Food and Drug Administration (FDA) requires manufacturers, distributors, and importers to submit adverse event reports for both prescription and over-the-counter (OTC) drugs. These reports help the FDA monitor product safety and take corrective actions when necessary, such as updating labeling, issuing safety communications, or initiating recalls.

Key post-market reporting requirements include:

FAERS (FDA Adverse Event Reporting System): Used for monitoring adverse events, medication errors, and product safety trends.

MedWatch Program: FDA’s voluntary and mandatory reporting system for healthcare professionals, patients, and manufacturers.

Serious Adverse Event Reporting: Mandatory submission of life-threatening, fatal, or medically significant adverse events within strict timelines.

Periodic Safety Update Reports (PSURs): Continuous monitoring and submission of cumulative safety data to FDA.

Risk Management & Mitigation Plans (REMS): Required for certain drugs to ensure benefits outweigh risks.

At XPRO America, we provide expert support for pharmacovigilance and FDA reporting compliance. Our services include:

Establishing compliant adverse event reporting systems for drug manufacturers and distributors.

Assisting with MedWatch and FAERS submissions.

Developing standard operating procedures (SOPs) for pharmacovigilance activities.

Supporting post-inspection corrective actions for FDA findings.

Preparing companies for safety audits and pharmacovigilance inspections.

With growing FDA oversight, strong pharmacovigilance practices are no longer optional—they are mandatory for market sustainability. By partnering with XPRO America, companies can reduce compliance risks, maintain FDA trust, and protect patient safety.

XPRO America provides FDA pharmacovigilance & post-market reporting support. Stay compliant with FAERS, MedWatch, and adverse event reporting requirements.

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OTC Drug Monograph Compliance & FDA Labeling Support – XPRO America

Over-the-counter (OTC) drugs play a vital role in the U.S. healthcare market, allowing consumers to access safe and effective treatments without a prescription. To ensure public safety, the U.S. Food and Drug Administration (FDA) regulates OTC products under the OTC Drug Monograph system. Compliance with these monographs is mandatory for manufacturers, packers, relabelers, and distributors of OTC medicines.

An OTC Drug Monograph specifies the active ingredients, dosage forms, labeling requirements, and testing standards for categories of OTC drugs such as cough and cold remedies, pain relievers, antacids, sunscreens, and anti-dandruff shampoos. Products that meet the monograph requirements can be legally marketed in the U.S. without submitting a New Drug Application (NDA). However, failure to comply with the detailed monograph regulations may result in misbranding or adulteration issues, leading to FDA enforcement actions.

Key areas of compliance include:

Formulation checks to ensure only permitted active ingredients and concentrations are used.

Labeling reviews in line with FDA requirements, including drug facts panels, directions, and warnings.

Claims assessment to avoid crossing into prescription-only or unapproved drug territory.

Good Manufacturing Practices (GMP) compliance under 21 CFR Part 210/211.

AtXPRO America, we provide specialized support to help pharmaceutical companies, contract manufacturers, and distributors achieve OTC drug monograph compliance with confidence. Our services include:

Comprehensive formulation and ingredient reviews

Labeling compliance checks for FDA-approved Drug Facts formatting

Guidance on transitioning to the new OTC Monograph Reform system under the CARES Act

Regulatory strategy for products that fall outside an existing monograph (requiring NDA or alternative pathways)

Ongoing compliance monitoring to keep pace with FDA updates

By working with XPRO America, companies can reduce regulatory risks, accelerate market access, and maintain FDA compliance for their OTC products. Whether you are marketing cough syrups, pain relievers, sunscreens, or other self-care medications, our expert team ensures your products meet the highest standards of safety, efficacy, and regulatory approval.

XPRO America helps companies achieve FDA OTC Drug Monograph compliance with formulation checks, labeling reviews, and regulatory guidance for safe U.S. market entry.

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XPRO America – FDA Import Compliance & Customs Clearance Support

Importing Active Pharmaceutical Ingredients (APIs) and finished drug products into the United States requires strict compliance with U.S. Food and Drug Administration (FDA) and U.S. Customs & Border Protection (CBP) regulations. Any gaps in registration, labeling, or documentation can result in detention, refusal, or costly delays at U.S. ports of entry. To ensure smooth entry, companies must have complete and accurate filings before shipment.

The FDA regulates the importation of pharmaceutical products under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Every foreign manufacturer, repacker, relabeler, or distributor must have a valid Drug Establishment Registration and listed drug products (with assigned National Drug Codes – NDCs). Additionally, a U.S. Agent is required for foreign facilities to handle FDA communications.

Common challenges companies face when importing APIs and drugs include:

Incomplete Registration – Shipments detained because the manufacturer or product is not registered or listed with FDA.

Improper Labeling – Labels not meeting FDA 21 CFR 201 requirements can trigger refusal at customs.

Missing Documentation – Lack of Prior Notice, commercial invoices, or certificates of analysis.

Customs Hold or Detention – FDA may issue an Import Alert, resulting in significant delays.

At XPRO America, we specialize in import compliance and customs clearance support for pharmaceutical companies worldwide. Our services include:

FDA Registration & Drug Listing Assistance to ensure all facilities and products are correctly registered.

U.S. Agent Representation to manage FDA communication on behalf of foreign companies.

Prior Notice Filing for shipments to ensure timely FDA notification.

Labeling & Documentation Review to avoid detention at U.S. ports.

Customs Clearance Support by coordinating with CBP and FDA for smooth entry.

Import Alert Resolution Guidance in case of detention, refusal, or regulatory enforcement.

By partnering with XPRO America, pharmaceutical manufacturers and exporters can minimize regulatory risks, prevent shipment delays, and ensure a seamless import process into the U.S. market.

XPRO America ensures FDA import compliance & customs clearance for APIsand finished drugs. Avoid shipment detention with expert registration & filing support.

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FDA Inspection & Audit Readiness Services for Compliance – XPRO AMERICA

For companies that manufacture, package, or distribute FDA-regulated products, inspection and audit readiness is critical to maintaining compliance and avoiding enforcement actions. The FDA routinely conducts inspections, including at foreign facilities exporting to the U.S., to ensure adherence to regulatory standards. Lack of preparedness can result in Warning Letters, Import Alerts, product seizures, or even facility shutdowns.

At XPRO AMERICA, we provide complete FDA inspection readiness and audit preparation services designed to help organizations identify compliance gaps, strengthen documentation, and build robust quality systems that withstand FDA scrutiny.

Key Services:

Mock Audits: We conduct FDA-style mock inspections to simulate real regulatory audits, identifying deficiencies and providing corrective guidance.

Compliance Documentation Review: Our experts audit Standard Operating Procedures (SOPs), batch records, CAPA files, and training logs to ensure documentation aligns with FDA expectations.

Foreign Facility Preparation: For non-U.S. manufacturers, we provide specialized guidance on U.S. FDA inspection protocols, ensuring that facilities exporting to the U.S. are fully prepared.

CAPA (Corrective and Preventive Action) Planning: We help organizations develop and implement CAPA systems to address nonconformities and prevent recurrence.

Regulatory Training: Our team conducts training sessions for staff to handle FDA inspector interactions, ensuring confidence and professionalism during audits.

Post-Inspection Support: If issues arise during an FDA inspection, we assist in preparing effective responses and remediation plans to avoid escalation.

Why Choose XPRO AMERICA?

Experienced team with deep knowledge of FDA inspection protocols.

Tailored audit readiness programs for pharmaceuticals, medical devices, supplements, and cosmetics.

Proactive compliance approach to minimize regulatory risks.

End-to-end support from mock audits to post-inspection corrective actions.

With XPRO AMERICA’s FDA inspection readiness services, your company can approach FDA audits with confidence, knowing that your documentation, systems, and staff are fully aligned with U.S. regulatory requirements. Our proactive strategies not only minimize risks but also strengthen long-term compliance culture.

XPRO AMERICA prepares companies for FDA inspections with mock audits, CAPA planning, and compliance documentation for smooth regulatory readiness.

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FDA Drug Listing & NDC Number Assignment (SPL Submissions) – XPRO America

The US FDA Drug Listing process is a mandatory compliance requirement for all human and veterinary drug products marketed in the United States. Under 21 CFR Part 207, every registered drug establishment must submit detailed information about each drug product they manufacture, repack, relabel, or distribute. This process ensures the FDA maintains an accurate and up-to-date database of all drugs available in the U.S. market.

A critical part of this process is obtaining and maintaining a valid National Drug Code (NDC) number. The NDC is a unique, 10-digit, 3-segment identifier assigned to each drug product, which provides essential information including the labeler code, product code, and package code. The NDC is widely used by healthcare providers, pharmacies, insurers, and regulators to identify and track drug products throughout the supply chain.

Drug Listing must be submitted electronically to the FDA in Structured Product Labeling (SPL) format. The SPL submission includes details such as:

Proprietary and established drug name

Dosage form, strength, and route of administration

Active and inactive ingredients

Packaging information

Labeling images and prescribing information (if applicable)

Maintaining an accurate and updated drug listing is not optional. Failure to list or update drugs with the FDA can result in:

Import refusals for foreign facilities

Product recalls or market withdrawal

Enforcement actions, including warning letters

At XPRO America, we specialize in assisting pharmaceutical companies with:

NDC Number Assignment for all marketed drug products

SPL Document Preparation and Submission through FDA’s ESG system

Ongoing Updates to maintain compliance when formulations, labeling, or packaging changes occur

Biennial Renewal Support to keep drug listings active and compliant

With XPRO Americaas your compliance partner, your company can confidently market pharmaceutical products in the United States, knowing that your Drug Listing and NDC assignments are handled with accuracy and in full compliance with FDA requirements.

XPRO America provides expert support for FDA Drug Listing, NDC number assignment, and SPL submissionsto keep pharmaceutical products compliant in the U.S.

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USFDA Support & Renewal 5 Years Package – The Smartest Way to Build Trust for Your Business by XPRO America

If you want to expand your business into the U.S. or boost your brand credibility worldwide, FDA registration is not optional it is essential. Customers, importers, and even online platforms trust businesses that are registered and verifiable. That’s where the USFDA Registration Package by XPRO America on abn.us.com becomes a complete solution for ambitious businesses like yours.

What is the USFDA Registration Package?

The package is a one-time solution designed for businesses and professionals who need credibility, compliance, and trust in the global marketplace. For just $5,000, you receive:

A Business A-I-R-S Number for your company.

An Individual A-I-R-S Number for your authorized representative.

A Verified Website Seal you can display on your site to prove credibility.

A verification API that allows your credentials to be validated online.

Five years of free renewal & support so you never worry about annual renewal stress.

Every business that deals in food, cosmetics, dietary supplements, medical devices, or exports to the USA must meet FDA requirements. Without registration, you risk delays, rejected shipments, and loss of trust with partners.

On the other hand, when customers and importers see your verification seal and A-I-R-S number, they know your business is authentic, compliant, and trustworthy. This credibility can help you:

Enter new markets confidently.

Close deals faster with global buyers.

Build long-term trust with partners and customers.

Long-Term Value

Unlike many compliance services that require yearly fees, the USFDA Registration Package includes five full years of renewal and support at no extra cost. That means one payment secures your business identity for half a decade an unbeatable value for exporters, manufacturers, and e-commerce sellers.

How to Get Started

Getting registered is simple:

Visit the USFDA Registration Package page.

Fill out the quick form with your details.

Complete payment via secure bank transfer or online.

Receive your A-I-R-S numbers, verification seal, and support instantly.

If you want your business to grow internationally, compliance and trust are your biggest assets. The USFDA Registration Package by XPRO America gives you both without the yearly hassle. With verified credentials, your business looks stronger, more reliable, and ready for global opportunities.

Secure your USFDA Registration today and give your business the credibility it deserves.

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FDA Drug Labeling Compliance & SPL Submission Services – XPRO America

Accurate and compliant drug labeling is one of the most critical requirements for marketing human and veterinary drugs in the United States. Under 21 CFR Part 201, the U.S. Food and Drug Administration (FDA) sets forth detailed labeling rules to ensure that healthcare providers and consumers have access to safe, reliable, and consistent product information.

Drug labels provide essential information such as dosage instructions, indications, contraindications, warnings, inactive ingredients, and proper usage. Any errors, omissions, or misleading claims can result in FDA enforcement actions, product recalls, or misbranding violations. For this reason, drug labeling compliance is a key focus area for all pharmaceutical manufacturers, repackers, relabelers, and distributors.

A major requirement of FDA compliance is Structured Product Labeling (SPL) formatting. This electronic standard ensures that drug labeling information is submitted in a consistent, machine-readable format through the FDA’s Electronic Submissions Gateway (ESG). FDA-approved SPL formatting is mandatory for both initial drug listings and ongoing updates.

Key aspects of 21 CFR 201 drug labeling compliance include:

SPL formatting for structured submissions, ensuring compatibility with FDA databases.

Label claims and warnings review, preventing misbranding and ensuring accuracy.

Inactive ingredient verification against the FDA’s Inactive Ingredient Database (IID).

Drug Facts and package insert compliance with FDA labeling standards.

Monitoring regulatory updates to keep labels aligned with FDA changes.

At XPRO America, we help pharmaceutical companies, drug manufacturers, and distributors achieve full compliance with FDA drug labeling requirements. Our specialized services include:

SPL formatting and electronic submissions through ESG.

Comprehensive labeling review for claims, directions, and warnings.

Inactive ingredient compliance checks using FDA databases.

Ongoing compliance monitoring to meet evolving FDA regulations.

Corrective support in case of FDA label deficiencies or enforcement actions.

With our expertise, companies can confidently market their drug products in the U.S. without facing delays or regulatory setbacks. XPRO America ensures your drug labeling meets FDA standards, protects patient safety, and supports seamless market entry.

XPRO America ensures FDA-compliant drug labeling with SPL formatting, claims review, and inactive ingredient checks to meet 21 CFR Part 201 requirements.

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FDA DMF Preparation & Filing for APIs, Excipients & Packaging – XPRO America

A Drug Master File (DMF) is a confidential, detailed submission to the U.S. Food and Drug Administration (FDA) that provides information about the facilities, processes, and materials used in the manufacturing, processing, packaging, and storing of human drugs. While not legally required, DMFs are critical for companies that want to supply Active Pharmaceutical Ingredients (APIs), excipients, or packaging components to drug manufacturers seeking FDA approval.

By submitting a DMF, suppliers protect proprietary information while enabling drug product manufacturers to reference the DMF in their Investigational New Drug (IND), Abbreviated New Drug Application (ANDA), or New Drug Application (NDA) submissions. This streamlines the approval process without requiring full disclosure of sensitive manufacturing details to third parties.

Types ofDMFsinclude:

Type II – For APIs, drug substances, and intermediates.

Type III – For packaging materials in direct contact with drug products.

Type IV – For excipients, colorants, flavors, or other additives.

Type V – For FDA-accepted reference information not covered under other types.

Maintaining an active DMF requires regular updates to reflect changes in manufacturing processes, facilities, quality systems, or raw material sourcing. Failure to update a DMF can result in FDA delays, deficiencies, or rejection of related product applications.

AtXPRO America, we assist companies with:

DMF preparation and formatting as per FDA’s electronic submission requirements.

Confidentiality protection while allowing client companies to cross-reference the DMF.

Gap analysis and compliance review to ensure completeness and accuracy.

Electronic submission through the FDA ESG (Electronic Submissions Gateway).

Ongoing maintenance and updates to keep DMFs current and aligned with FDA standards.

Our experts ensure that your DMF submission is comprehensive, compliant, and properly structured for seamless FDA review. With our guidance, suppliers can expand their market reach, enhance partnerships with drug product manufacturers, and ensure regulatory acceptance.

XPRO America provides FDA DMF preparation, filing, and maintenance services for APIs, excipients, and packaging components under Type II, III, IV, and V DMFs.

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XPRO America – Controlled Substances Compliance (DEA & FDA)

Compliance with controlled substances regulations is one of the most highly regulated areas in the U.S. pharmaceutical industry. Companies dealing with narcotics, psychotropics, or precursor chemicals must comply with both the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA). Overlapping requirements make compliance complex, requiring detailed knowledge of scheduling, security, and reporting obligations.

Controlled substances scheduling is established under the Controlled Substances Act (CSA). Drugs are classified into five schedules (I–V) based on their medical use, abuse potential, and safety profile. Sponsors, manufacturers, distributors, and researchers must understand the classification of their products to determine the applicable restrictions and authorization requirements.

Key compliance elements include:

Scheduling Guidance – Determining whether a substance is listed under Schedule I–V and ensuring correct handling protocols.

DEA Registration – Mandatory for facilities involved in manufacturing, distribution, research, import, or export of controlled substances.

FDA Compliance – Labeling, clinical trial oversight, and product approval processes for drugs that also fall under FDA jurisdiction.

Import/Export Authorization – DEA Form 357 (import) and DEA Form 236 (export) submissions, along with FDA prior notice requirements.

Security & Recordkeeping – Maintaining stringent controls to prevent diversion, including inventory logs, restricted access, and reporting.

Reporting Obligations – ARCOS (Automation of Reports and Consolidated Orders System) filings, theft/loss notifications, and adverse event reports.

At XPRO America, we support clients in navigating this complex DEA–FDA compliance overlap by offering:

Controlled Substance Scheduling Reviews to assess product classification.

DEA & FDA Registration Assistance for manufacturing, research, and distribution facilities.

Import/Export Authorization Support to streamline cross-border movement of scheduled substances.

Inspection & Audit Preparation for both DEA and FDA regulatory inspections.

Ongoing Compliance Monitoring to ensure adherence to evolving regulatory updates.

With our expertise, companies can avoid enforcement risks, delays, and penalties while maintaining uninterrupted business operations. Our tailored solutions provide the assurance that your controlled substance operations are fully compliant with both DEA and FDA regulations.

XPRO America helps with DEA & FDA controlled substances compliance, scheduling guidance, registration, and import/export authorization support.

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XPRO America – Clinical Trial IND Application & FDA Support Services

Launching a new drug in the United States requires rigorous compliance with FDA regulations, starting with the Investigational New Drug (IND) application. An IND is mandatory before beginning any clinical trials involving human subjects. It ensures that the investigational product is safe for testing and that the study design meets ethical and scientific standards.

The IND submission allows sponsors to legally ship an investigational drug across state lines and administer it to humans for research purposes. This process is critical for both pharmaceutical innovators and biotechnology companies looking to bring novel therapies to market.

Key components of a successful IND include:

Preclinical Data – Animal pharmacology and toxicology studies to demonstrate safety.

Chemistry, Manufacturing, and Controls (CMC) – Information about drug composition, stability, and manufacturing processes.

Clinical Protocols – Study design, dosing, patient population, and monitoring procedures.

Investigator Information – Qualifications of clinical investigators and participating institutions.

The FDA reviews IND submissions to ensure patient safety and compliance with Good Clinical Practice (GCP). Sponsors must also maintain ongoing communication with the FDA throughout the clinical trial process, including annual reports, safety updates, and protocol amendments.

At XPRO America, we provide end-to-end Clinical Trial IND Support Services to streamline this complex process:

IND Application Preparation – Compiling CMC, preclinical, and clinical data in the required format.

Clinical Protocol Development – Designing scientifically sound and FDA-compliant study protocols.

Regulatory Liaison – Communicating with the FDA during the review process and throughout the trial.

Compliance Monitoring – Ensuring adherence to GCP and FDA reporting requirements.

Ongoing IND Maintenance – Submitting amendments, annual reports, and safety updates.

With our expertise, sponsors can reduce delays, avoid regulatory pitfalls, and ensure their investigational drugs move efficiently through the clinical development pipeline.

XPRO America offers FDA IND support for clinical trials, including application prep, protocol design, and regulatory communication for safe, compliant studies.

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FDA cGMP Compliance & 21 CFR 210/211 Audit Support – XPRO America

Compliance with Current Good Manufacturing Practices (cGMP) is mandatory for all pharmaceutical manufacturers, repackers, relabelers, and distributors who want to market drug products in the United States. Governed under 21 CFR Parts 210 and 211, cGMP regulations establish the minimum requirements for methods, facilities, and controls used in the manufacturing, processing, and packaging of drug products.

Failure to comply with FDA cGMPstandards can result in warning letters, product recalls, import alerts, or facility shutdowns. Therefore, maintaining a strong quality management system and robust documentation processes is critical for regulatory approval and long-term business success.

Key areas of cGMP compliance include:

Facility design & equipment qualification to ensure a clean and controlled environment.

Comprehensive documentation review, including SOPs, master batch records, and QC logs.

Quality control & assurance systems for testing raw materials, intermediates, and finished products.

Batch record setup and maintenance, ensuring traceability from raw material to finished product.

Personnel training and hygiene practices to reduce contamination risks.

Internal audits and mock FDA inspections to identify and correct deficiencies before regulatory review.

At XPRO America, we support pharmaceutical companies by conducting cGMP compliance audits and preparing facilities for FDA inspections. Our services include:

Gap analysis audits to identify non-compliance issues.

Documentation preparation and review for 21 CFR 210/211 alignment.

Quality system setup including CAPA, deviations, and change control processes.

Batch record development and verification to ensure traceability and accountability.

Audit readiness training for staff to handle FDA inspections effectively.

With our guidance, drug manufacturers can establish strong compliance frameworks, reduce regulatory risks, and ensure that their products meet FDA quality standards. XPRO America helps you stay inspection-ready and compliant with 21 CFR Parts 210 & 211, ensuring safe and effective drug products for U.S. markets.

XPRO America provides FDA cGMP compliance audits, documentation review, and quality system support under 21 CFR Parts 210 & 211 for drug manufacturers.

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XPRO America – FDA Annual & Ongoing Compliance Services for Drug Firms

For companies manufacturing, repacking, relabeling, or distributing human and veterinary drugs, annual and ongoing compliance with the U.S. Food and Drug Administration (FDA) is a mandatory responsibility. Non-compliance can lead to penalties, product recalls, import alerts, and loss of market access in the United States.

XPRO America specializes in providing Annual & Ongoing Compliance services to ensure pharmaceutical businesses remain aligned with FDA regulations year-round. Our expert support helps companies maintain drug establishment registrations, update drug listings, and stay informed of evolving FDA requirements.

Compliance does not end after initial registration it is an ongoing obligation. The FDA requires companies to renew and update critical information regularly, and failure to do so can cause severe disruptions to business operations. At XPRO America, we offer comprehensive compliance management tailored to your business needs, including:

Establishment Registration Renewal: Ensuring timely renewal of FDA drug establishment registrations to prevent lapses that could lead to suspended operations or import holds.

Drug Listing Updates: Managing updates to the National Drug Code (NDC) database through Structured Product Labeling (SPL) submissions, covering any new formulations, packaging, or discontinued products.

Regulatory Monitoring: Continuously tracking updates in FDA regulations, guidance documents, and enforcement trends to keep your compliance strategy up to date.

Ongoing Advisory Support: Acting as your compliance partner to answer FDA queries, prepare documentation, and assist with inspections or audits.

Risk Mitigation: Helping companies avoid costly compliance errors by proactively identifying potential gaps and implementing corrective actions.

WithXPRO America, companies gain confidence that their regulatory requirements are not only met but also strategically managed to support long-term success. Our goal is to reduce compliance risks while enabling uninterrupted access to the U.S. market.

Partnering with us means your company can focus on innovation and business growth while we handle the complexity of FDA compliance renewals, reviews, and updates.

XPRO America ensures FDA compliance with registration renewals, drug listing updates, and ongoing regulatory monitoring for pharmaceutical companies.

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XPRO America – ANDA Bioequivalence (BE/BA) Studies & CRO Coordination

To bring a generic drug to the U.S. market, sponsors must file an Abbreviated New Drug Application (ANDA) with the FDA. A key requirement of the ANDA process is proving bioequivalence (BE) between the proposed generic and the reference listed drug (RLD). Bioequivalence demonstrates that the generic delivers the same therapeutic effect, safety, and efficacy as the innovator drug.

Bioequivalence (BE) and Bioavailability (BA) studies play a crucial role in establishing therapeutic equivalence. These studies measure the rate and extent of drug absorption, ensuring that the generic performs comparably to the branded product in human subjects.

Typical requirements for BE/BA studies include:

Conducting these studies requires expertise in regulatory strategy, clinical research, and data integrity. Most sponsors collaborate with a Contract Research Organization (CRO) to perform the clinical and analytical phases of BE studies.

At XPRO America, we specialize in ANDA Bioequivalence Studies Coordination by:

Our services help sponsors minimize delays, reduce risks, and achieve timely FDA approvals for their generic drug products. By aligning scientific requirements with regulatory expectations, XPRO America ensures your ANDA bioequivalence studies are executed with precision.

XPRO America provides ANDA bioequivalence (BE/BA) study support, protocol design, CRO coordination, and FDA-compliant submissions for generic drug approvals.

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ANDA & NDA Submissions Support for FDA Drug Approvals - XPRO America

Bringing a pharmaceutical product to the U.S. market requires rigorous regulatory approval by the U.S. Food and Drug Administration (FDA). For drug manufacturers, this process involves filing either an Abbreviated New Drug Application (ANDA) for generic drugs or a New Drug Application (NDA) for novel, innovative drugs.

The ANDA pathway is designed for companies developing generic drug products that are bioequivalent to approved reference drugs. Successful ANDA approval allows manufacturers to market cost-effective generic versions while maintaining FDA’s strict standards for safety, efficacy, and quality.

The NDA pathway, on the other hand, is required for new and innovative drugs that have not previously been approved in the U.S. market. An NDA submission must include extensive data from preclinical studies, clinical trials, manufacturing processes, labeling, and safety assessments. Approval through this route grants companies the ability to commercialize groundbreaking pharmaceutical products in the U.S.

Both ANDA and NDA submissions must be compiled and submitted in the electronic Common Technical Document (eCTD) format, which requires technical expertise and strict compliance with FDA submission standards.

At XPRO America, we specialize in guiding pharmaceutical companies through the ANDA and NDA submission process, ensuring that applications are complete, compliant, and submitted successfully. Our services include:

With our expertise, drug manufacturers can streamline the complex submission process, avoid delays, and increase their chances of FDA approval. Whether you are filing a generic ANDA or a novel NDA, XPRO America provides the regulatory support needed to bring your pharmaceutical products to the U.S. market with confidence.

XPRO America provides expert support for FDA ANDA & NDA submissions, including eCTD compilation, bioequivalence studies, and full regulatory guidance.