Our Role in your Application Process for EU Clinical Trials 

A QP Declaration has to be submitted with each EU clinical trial application for any process (e.g. manufacturing, analytical testing) performed outside the EU.  

We will work with you to assess Good Manufacturing Practice (GMP) compliance of operations at your partner facilities from Active Pharmaceutical Ingredient (API) Manufacture, IMP manufacture, testing and packaging.  

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Based on the assessment, we will conduct any necessary QP audits and provide reports as required. We will work with the facilities to close out any observations and then we will sign the QP declaration for your project to submit with your Clinical Trial Application (CTA). 

We will work with you to provide the QP declaration to meet your EU submission timescale.

Whilst your application is being processed within the EU we will advise you on the documents required to build the Product Specification File (PSF) which will be held and  maintained at IMP Baprol.  All technical documents will be proactively reviewed, these technical documents to facilitate timely QP certification upon CTA approval. 

 

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​Our Experience Covers: 

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• All aspects of CMC, packaging, testing and drug product release

• Sterile, Advanced Therapy Medicinal Products (ATMPs) and non-sterile products

• Dosage forms including but not limited to:  tablets, capsules, liquids, creams, ointments, gels and biotech products

• Our two QPs have over 20 years combined experience within the contract pharmaceutical industry 

• GB QP Oversight for clinical material already released in the EU with import support can be facilitated via our colleagues at IMP Pharmaceutical Services Ltd.

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Qualified Persons are a requirement under EU Clinical Trial Regulation 536/2014 and delegated Regulation 2017/1569.