Biotec’s QP Consultancy service
Are you seeking to bring a new product to market within Europe? Biotec can provide a specialist QP Consultancy service offering expert advice by telephone, e-mail or in person, to guide you through current legislation and ensure that your pharmaceutical operations are in compliance with all relevant EU Directives and GMP guidelines.
Our QPs will:
- Provide a unique ‘Product Supply Route Map’ to guide you to the correct 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 complied with, prior to certifying the product
- Provide advice on manufacturing site selection
- For commercially available, marketed products, our QPs will certify the product in accordance with the relevant marketing authorisation - for example the Medicinal Products for Human Use Directive 2001/83/EC and GMP Directive 2003/94/EC
