Unlocking New Levels of Compliance and Efficiency with VelaLabs’ Expanded Services
Introducing Our Expanded GMP-Certified Testing and QP Release Services
VelaLabs is proud to announce the successful expansion of our Manufacturing and Importation Authorisation (MIA) and GMP certification. This expansion now includes 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.
This significant enhancement of our services enables us to offer comprehensive support at every level of the drug supply chain, helping to streamline your operations and reduce the complexity of vendor management.
Why Choose VelaLabs for QP Release?
Our team of highly experienced Qualified Persons (QPs) plays a pivotal role in ensuring that your product meets the highest standards of safety, efficacy, and compliance. Here’s how we can assist:
- 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
Leveraging Our Strategic Location for Global Reach
Located in the heart of Europe, VelaLabs is strategically positioned to leverage the EMA’s harmonized regulatory framework. 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.
Partner with VelaLabs
At VelaLabs, we are committed to supporting your journey from development to market with our expanded range of services. By choosing us as your partner, you are ensuring that your product is safe, compliant, and ready for distribution across multiple markets.
Discover how VelaLabs can enhance your supply chain efficiency and safeguard your product’s success. Interested in working with an independent CLO with a personal approach? Click here and get in touch with us