Indivirtus Healthcare Services
As a Contract Research Organization (CRO), Indivirtus Healthcare Services offers a wide range of services within the pharmaceutical and healthcare sectors. Initially, the company specialized in delivering Toxicological Risk Assessment Reports to pharmaceutical manufacturers. However, over time, it has expanded its service offerings to include numerous other services.
Established in 2018, Indivirtus Healthcare Services began its journey in a modest single-room office, staffed by just two individuals, led by Dr. Upendra Jain and Ms. Veena Kumari. Over the span of six years, this humble organization has evolved into a group of five companies, boasting seven offices worldwide and a workforce of over 100 employees. Indivirtus Healthcare Services has successfully served more than 500 clients across over 45 countries.
The range of services provided by Indivirtus Healthcare Services includes:
Toxicology:
Toxicology is the scientific field that involves the study of the harmful effects of chemicals on living organisms.
Cleaning Validation: This service ensures cleanliness to prevent contamination during production processes. It is achieved by calculating MACO (maximum allowable carryover) values based on health-based exposure limits such as PDE (Permitted Daily Exposure), ADE (Allowed Daily Exposure), and OEL (Occupational Exposure Limit), all established through thorough risk assessments. These reports adhere to guidelines set by EMA, ICH, APIC, AND PICS.
Genotoxic Evaluations of Impurities: Utilizing ICH M7 guidelines, this service assesses the genotoxicity and mutagenicity of impurities to determine their acceptability in drug substances and products.
Material Safety Data Sheets (MSDS): These provide detailed information on the safety and handling of materials.
GRAS Reports: These confirm the safety of substances for their intended use.
Regulatory Affairs/Regulatory Affairs (RA/Reg Affairs)
Preparation and Submission of CTD, ACTD & e-CTD Dossiers
Dossiers for Regulated, Semi-regulated, and WHO Regulated Market
CEP Filing & Submission on the EDQM Portal and DMF Filing to the FDA
Clinical & Non-Clinical Overviews and Summaries
Batch Releasing & Testing Site Service for Europe (BRS & BTS)
MAH & Local Agent Service for Europe & US
Pharmacovigilance and Drug Safety Services
PSMF Management
Single Case and Adverse Event Reporting
Aggregate Report Generation
Safety Physicians Support
Signal Management & Safety Surveillance
Literature Monitoring (Global and Local)
Medical Writing
Risk Management Plans (RMPs)
Electronic Submission Management
Medical Information Call Centre (MICC)
Qualified Person for Pharmacovigilance (QPPV) Support
Regulatory Authority Requests and Audit/Inspection Readiness
Social Media Monitoring for Adverse Events
Calibration Services
Indivirtus Healthcare Services is equipped to provide a variety of calibration services through a facility accredited by NABL (National Accreditation Board for Testing and Calibration Laboratories) (ISO/IEC: 17025:2017). Our calibration services cover a broad spectrum, including:
Calibration Facility in various dimensions, pressure, mass, volume, RPM, sound, electro-technical, and thermal.
Temperature Mapping and Validation Facility for Furnace, Chambers, Oven, and Cold Storage.
On-site Facility for Calibration.
Training on Quality Systems & Implementation.
Computerized System Validation (CSV)
Indivirtus Healthcare Services is dedicated to providing comprehensive services in CSV to ensure that systems are performing their intended tasks effectively. Our CSV services include:
Implementation and Validation of Computerized Systems.
Decommissioning of Computerized Systems.
Cloud Systems Validation.
Quality Systems for IT Departments and IT Service Suppliers.
Quality Systems for Software Validation.
Computer Infrastructure Qualification.
Audits for IT Solution Suppliers.
Training.
Clinical Research & Equivalence Studies
Indivirtus Healthcare Services provides a range of clinical research services, including feasibility assessments, participation in regulatory discussions, project oversight, management of clinical sites, handling of data and statistical analysis, and the conduct of Phase I, II, III clinical studies.
Technology Transfer (Tech Transfer)
Indivirtus Healthcare Services specializes in technology transfer services, facilitating the transition of drug substance production processes from research laboratories to commercial facilities. Our services include CMO (Commercial Manufacturing) site transfers and CMDO (Research and Development to Commercialization) services. We handle various aspects of technology transfer, such as:
Site transfers
Research and Development/Funding and Development
Dossiers/Know-how
Good Manufacturing Practices (GxP) and Auditing Services
Indivirtus Healthcare Services offers a variety of audit services to help identify and address deficiencies in processes, ensuring compliance. Our audit services include:
Internal audits and Good, Environment, Management, and Business Analysis (GEMBA) sessions
Third-party audits and Gap assessments
Pre-inspection and Due Diligence audits
Additional Services Provided by Indivirtus Healthcare Services include:
CMO/CDMO Facilities for the Sourcing of Formulations and Active Pharmaceutical Ingredients (APIs)
Greenfield/Brownfield Development Projects