GMP inspections are mandatory for products approval for many of the markets i.e. USA, EU, Australia, Brazil, South Africa, African countries, GCC, Ukraine etc. This step is very critical to define market entry of Pharmaceutical Company in global network.
We use our expertise in successful execution of GMP inspections for various Health Authorities. Our service covers:
- Site Master File Preparation, review of SOPs and related documents
- Arrange mock up audits from EU QP
- Prepare GMP Inspection documents and submit it to health Authority
- Liasoning with Agency for scheduling inspection
- Successful execution of GMP/GCP inspection
- Writing response, in case of exigencies & obtaining site approval