Our Qualified Person (QP) support services ensure that investigational medicinal products are managed, certified and released in full compliance with European regulatory requirements. Working closely with sponsors and manufacturing partners, our experienced QP team provides comprehensive oversight throughout the clinical supply chain.
Batch certification and release represent the final regulatory step before a product can be supplied for clinical use.
This critical process confirms that each batch has been manufactured, tested and controlled according to applicable regulatory standards before being made available to patients.
Our QP services include:
Our QP team plays a key role in maintaining the integrity and compliance of the clinical supply chain through comprehensive quality oversight activities.
These activities help ensure that all parties involved in the manufacture and distribution process operate within a robust quality framework.
Support includes:
For medicinal products manufactured outside the European Union, QP certification is required before distribution within the EU.
By combining regulatory expertise, GMP compliance oversight and QP certification capabilities, we provide sponsors with a reliable and efficient pathway for the release, importation and distribution of investigational medicinal products throughout Europe.
Our importation support services include:
