CRQA is an independent auditing and regulatory consulting based in Delhi, INDIA.
Our services involve full range of GCP, GLP, quality assurance audits, regulatory
support from feasibility to dossier submission on a global basis.
While working in Pharmaceutical industry, Our department 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 an 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