COREALIS PHARMA

RELEASE AND STABILITY

The COREALIS Pharma analytical group offers complete GMP analytical services for the GMP solid oral solid dosage forms manufactured by COREALIS Pharma. Both groups work in close collaboration with one another and coordinate their efforts in order to deliver the drug products on time, every time.

Analytical methods receive phase appropriate qualification/ validation according to ICH guidelines and respectful of regulatory requirements specific to the countries where the clinical studies are held (US, Europe or Canada).

These analytical services include:

• Phase appropriate qualification/ validation of analytical methods for API
  and drug product release testing,
• cGMP release testing of APIs and drug products,
• cGMP release testing of excipients and packaging materials,
• cGMP stability storage and testing,
• Analytical methods validation for cleaning verification,
• GMP Analysis for cleaning verification,
• Analytical methods transfer to a cGMP laboratory of the client’s choice.