Analytical Development, Stability and Release

When it’s time for regulatory submission, we support you with high quality CMC analytical data compliant with GMP and other regulatory standards. Build on our decades of experience in providing GMP analytical support to the biopharmaceutical industry.

We offer you:

• API, drug product and quality control testing
• API and drug product stability studies Monitoring and identification of data trends─ control charting & review
• API Reference Standard Management & Control
• Batch release
• QP certification and release for investigative medicinal products
• Microbiological testing
• Performance testing of inhaled products
• Extractable and leachable testing