Your Trusted Partners for Quality Assurance and Regulatory Services…
WHY ARE WE HERE?
YOUR TRUSTED PARTNERS FOR GXP AUDITING SERVICES
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Some of our Recent Projects :
- GCP audit of the CRO and the investigator sites for leading European medical device company. Critical findings led the termination of CRO.
- GCP audit of the leading global CRO.
- For Cause’ Audit on behalf of big pharma of the global investigator site, prior to USFDA inspection.
- Preparation of end-to-end SOPs for Clinical Data Management and Biostatistics of the leading CRO conducing global studies, including GCP Training for regulatory inspection preparedness.
- Over 100 GCP Training Programs for CROs, Investigator Sites and Pharmaceutical companies.
- IMP Depot audit.
- Pharmacovigilance QA SOPs preparation for the leading CRO.
- Pharmacovigilance LPVRP SOPs preparation for Asia Pacific Region.
- GMP Audit of Indian pharma manufacturing facility on behalf of leading global NGO.
- Ethics Committee Formation, Regulatory Compliances and Training.
- Pre inspection GLP trainings
For System Demo and further information, please call +91 98100 68241 or mail us at bd@crqa.in