QP & GMP Consultancy

Qualified Persons (QPs) play a vital role in bringing products - especially new products - to market with Europe. Global clients look to the diverse range of skills and specialism of our highly experienced team of QPs to ensure their clinical studies, and commercial supply operations not only meet the most rigorous standards but also run smoothly, seamlessly and cost-effectively.

Quality expertise to guide and direct you

The diversity of experience within our ever-expanding team of Qualified Persons means we deal quickly and expertly with specific issues and technical challenges right across the pharmaceutical dosage spectrum, from small molecules to biopharmaceuticals and advanced therapeutic medicinal products.

Auditing manufacturing facilities anywhere in the world is part of this service, ensuring that each batch has been manufactured in accordance with cGMP guidelines.

So too is helping you to navigate the regulatory maze – bringing your products through every stage of your study using our ‘Product Supply Rout Map’.

In short, the Biotec QP team is there to help you at every stage.

Our QPs will:

• Provide a unique ‘Product Supply Route Map’ to guide you to the best solution for your clinical requirements
• Conduct audits of manufacturing facilities, including primary and secondary manufacturing operations, ensuring that each batch has been manufactured in accordance with cGMP guidelines
• Oversee the collection of your drug from its manufacturer and import the supplies into our licensed facility in the European Union (EU)
• Certify your IMP for use in clinical trials in Europe in accordance with the Clinical Trials Directive 2001/20/EC
• Certify the finished product prior to release
• If the product is a comparator, our QPs will ensure that all necessary controls are compiled prior to certifying the product
• For commercially available, marketed products, our QPs will certify the product in accordance with the relevant marketing authorisation

• Manufacturing Licence MIA (IMP) 19819
• Manufacturers Licence ML/19819/1
• Manufacturers Specials Licence MS/19819
• Wholesaler Dealer Licence WL/19819/1
• Home Office Controlled Drugs Licence