CRQA is an independent auditing and regulatory consulting head quartered in New Delhi, India. We offer our services in New Delhi NCR, Gurgaon, NOIDA, Mumbai, Pune, Bangalore, Chennai, Hyderabad, Kolkata, Ahmedabad, Vadodara and all other major cities of India through our network of QA professionals and auditors. Our services involve full range of GCP, GLP, GMP quality assurance audits, pharmacovigilance audits, inspection preparedness, regulatory support from feasibility to dossier submission on a global basis.

WHY ARE WE HERE?

While working in Pharmaceutical industry, we often felt the need to outsource GCP audits either due to resource constraints or because of specialized skills. We were always looking out for an agency who is dedicated into this space rather than outsourcing it to a CRO who offer QA along with other services. With large CROs, there were occasionally conflict of interest issues. It was seen that most of the CROs were uncomfortable to be audited by a competitor CRO. Furthermore, every CRO and Pharma company has a QA unit but to do a reality check of their own systems and procedures, they need to be evaluated by some external auditor who could give them a holistic view of how they can do better. Overall the benefits offered are:

• Getting the job done by skilled and experienced resources.
• No conflict of interest.
• Cost saving as we have region based auditors who will audit the vendor/site/lab wherever it is
• By outsourcing the auditing job, sponsor can enjoy better relationship with the CRO.