This function ensures that APIs, intermediates, and drug products are tested in full compliance with global regulatory standards (ICH, USP, EP, JP, etc.) throughout development and manufacturing. It provides high-quality analytical data necessary for regulatory submissions, product release, and lifecycle management.
Key Deliverables
- Finished Product Testing: Verification of identity, potency, purity, and dissolution of APIs and formulations.
- Release Testing: Batch release testing according to GMP requirements, including stability, assay, and impurity testing.
- Regulatory Documentation: Preparation of validated reports, certificates of analysis (CoA), and supporting data for IND, NDA, ANDA, DMF, and other filings.
- Method Compliance Checks: Ensuring all testing methods used are fully validated and compliant with regulatory expectations.
- Ongoing Stability & Shelf-life Studies: Testing under ICH-recommended conditions to support expiry dating and post-approval product monitoring.
- Quality Assurance Support: Coordination with QA/QC teams to ensure consistency and adherence to regulatory requirements.