Somerset House Consultants.mpg

Somerset House Consultants has long experience of design and management of pharmaceutical development, manufacturing, and quality assurance programmes. Founded in the UK in 2001, we have an international client base covering Europe, US, Japan, Australia and India. Our expertise covers Active Pharmaceutical Ingredients, Investigational Medicinal Products, sterile and non-sterile dosage forms and biotechnology products.

Our services include:

•Setting up GMP-compliant Quality Assurance systems
•Responding to FDA and EMEA deficiency letters
•Supplier audits
•Qualified Person Release of Active Pharmaceutical Ingredients (API), Investigational Medicinal Products (IMP) and commercial products
•Manufacture and Release of Clinical Trial Supplies
•Contractor selection and management
•Drafting GMP-compliant Quality Agreements with suppliers and contractors
•GMP compliance
•Interim management
•Staff training

Category:

Science & Technology

Tags:

• GMP
• pharmaceutical
• quality assurance
• API
• IMP
• clinical trials
• Good Manufacturing Practice
• EMEA
• MHRA
• FDA
• Somerset House Consultants
• GMP compliance
• GMP deficiency letter
• outsourcing
• contract manufacturer