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Somerset House Consultants
 
 
 
 
 

Our Services | Pharmaceutical Quality Assurance

We have wide experience in managing pharmaceutical quality assurance programmes and carrying out Good Manufacturing Practice audits for Active Pharmaceutical Ingredients, Investigational Medicinal Products and marketed products. We provide a range of services to ensure that you and your contractors meet all current requirements, including:

•  Virtual Quality Management™

Our Virtual Quality Management™ product is specifically designed to help small pharmaceutical companies to comply with regulatory requirements. A dedicated quality professional works directly for you on a part-time basis; much more cost-effective than employing a full-time employee or interim manager.

•  Supplier and contractor audits

Regulatory authorities require companies to audit all suppliers for GMP compliance. We regularly audit Active Pharmaceutical Ingredient, Investigational Medicinal Product and marketed product manufacturers on behalf of our clients.

•  Product Importation into the EU

Importers must ensure that non-EU manufacturers comply with EU Good Manufacturing Practice standards. We audit manufacturers worldwide, highlighting deficiencies and proposing solutions where necessary, and arrange analysis and Qualified Person release on importation into the EU.

•  Qualified Person release of marketed products and clinical trial supplies

We can provide contract Qualified Person services to cover temporary or long-term needs.

Recent Quality Assurance Projects -->

 

Contact Us

Tel:
+44 (0)1672 562225
E-Mail Us Here

Glossary of Terms

View our glossary of terms relating to Pharmaceutical Quality Assurance & Good Manufacturing Practice -->

© 2011 Somerset House Consultants, Specialists in Pharmaceutical Quality Assurance