Case Study 5: EU GMP Certification Support for an Indian API Supplier
Client: An Indian API manufacturer aiming to expand into the EU market
Challenge:
The client sought to obtain EU GMP certification to supply APIs to European pharmaceutical companies. However, gaps in their QMS and process validation protocols posed a major hurdle.
Solution by Qualifyo:
- Conducted a pre-certification mock audit to identify gaps.
- Provided compliance consulting, focusing on QMS enhancements, process validation, and data integrity.
- Trained the supplier’s QA/QC teams on EU GMP expectations.
- Assisted in documentation preparation and submission to the EU regulatory authority.
Outcome:
- The supplier obtained EU GMP certification within 6 months.
- The client secured long-term supply contracts with two major European pharma companies.
- Revenue increased by 40% due to successful entry into the EU market.
