Indivirtus

Indivirtus is a contract research organisation serving pharmaceutical, biotech and medical device companies. Its site describes end-to-end consulting that runs from toxicological risk assessment to regulatory approvals. The listing shows offices in India, the United States, the United Kingdom, Canada and the United Arab Emirates.

What Indivirtus does

• Toxicology and cleaning validation: exposure limit calculations such as ADE, PDE and OEL reports, plus genotoxic impurity and medical device assessments.
• Pharmacovigilance: support from database setup through to risk management plans.
• Regulatory affairs: help with GMP approvals from authorities including EU-GMP, USFDA, WHO-GMP and TGA.
• Calibration: NABL-accredited calibration of thermal, electro-technical, mechanical, pressure, mass and volume instruments.
• Validation and projects: computer system validation, HVAC and temperature mapping, and turnkey greenfield and brownfield facility projects.
• Training: courses on cleaning validation, GxP, data integrity and quality systems.

Clients

Pharmaceutical, biotech and medical device manufacturers, as well as wider healthcare organisations, in more than 64 countries according to the site.

Key facts

• Offices: Chandigarh and Mohali in India, Novi in Michigan, Sutton in England, Montreal and Dubai
• Accreditation: NABL for calibration services