QP Services
In 2024 we have expanded our Manufacturing and Importation Authorisation (MIA) and GMP certification. We offer Qualified Person (QP) certification and batch release capabilities for both Investigational Medicinal Products (IMPs) for clinical trials and medicinal products for human or veterinary use that hold a marketing authorisation (MA) or are made for export. The scope of this expansion also includes the importation and batch release of investigational and authorised medicinal products for EU entry.
We are fully equipped to manage product release not only within the European Union but also for UK or markets falling under a Mutual Recognition Agreement (MRA) e.g. USA, Japan, Israel.
Furthermore, we offer re-testing and confirmatory laboratory services for manufacturers outside of the EU/MRA regions, ensuring that their products meet the stringent standards required for batch release.
Our services:
Audit and Assurance - Our QPs can conduct thorough audits of your production facilities, identifying any potential compliance issues and working with you to develop a Corrective and Preventive Action (CAPA) plan. Upon a successful audit, we can issue a QP declaration to confirm that the active substance or investigational medicinal products have been manufactured in accordance with GMP
Batch Documentation Review - We meticulously review all batch records and related documentation to ensure compliance with regulatory requirements
Seamless Collaboration - We work closely with Marketing Authorisation Holders and Importers to facilitate a smooth and efficient release process, minimizing delays and ensuring that your product reaches the market as quickly as possible