COREALIS PHARMA

QUALITY SYSTEMS AND QUALIFICATIONS

The facility owned by COREALIS Pharma has been designed, built and used solely for the purpose of formulation development and clinical supply manufacturing of pharmaceutical solid oral dosage forms. It is a cGMP facility and the processes are in full compliance with the ICH guidelines.

COREALIS Pharma’s Quality Assurance group is composed of scientists with impressive industry experience in cGMP analytics and manufacturing operations. COREALIS Pharma’s quality systems are continuously improving as they are reviewed on a regular basis by auditors mandated by our clients including Qualified Quality Persons (QP). COREALIS Pharma underwent a successful general audit by a QP auditor, meaning that the QP auditor does not need to re-audit COREALIS Pharma for each manufacturing campaign of European clinical supplies. This translates into substantial time and cost savings for clients.

COREALIS Pharma’s goal is to provide its clients full satisfaction by providing high quality services and delivering compliant phase appropriate drug products on time every time.