Enteris has successfully developed a number of clinical drug candidates for both internal and client sponsored programs, giving us vast exposure and a thorough understanding of the rigorous quality and regulatory standards set forth by the health authorities.
We are in a unique situation to leverage our experience in both manufacturing and clinical development to support the quality and regulatory requirement of our partner sponsored programs. Enteris works within the expectations of guidelines set forth by the various health authorities and can design efficient development programs to complete a robust Drug Product regulatory submission. We have implemented over 300 internally developed standard operating procedures (SOPs) in our fully qualified cGMP facility.
- Systems compliant with FDA, EMA and ICH
- Customer focused, providing real time feedback on all quality related issues
- Full project participation: Formulation development → Process development → batch record design → GMP manufacture
- Method development and validation
- Concurrent Quality Assurance oversight of manufacturing operations
- Vendor auditing and qualification program
- ICH-compliant stability protocols and program with temperature- and humidity-controlled storage chambers on 24-hour computer-monitored system