Pharmaceutical Quality Assurance Specialists
Somerset House Consultants is a privately owned, independent, CRO with long experience of design and management of pharmaceutical development, manufacturing, regulatory affairs and quality assurance programmes.
We specialise in helping emerging and “virtual” pharmaceutical companies worldwide to select, audit and manage sub-contractors for their outsourced development and manufacturing projects. We are flexible and responsive to meet your specific needs.
Our services include:
Quality Assurance and Qualified Person Release of Active Pharmaceutical Ingredients (API), Investigational Medicinal Products (IMP) and marketed products
- ensuring that your products and suppliers comply with Good Manufacturing Practice
Manufacture and Release of Clinical Trial Supplies
- ensuring that your Investigational Medicinal Products are manufactured on-time and in compliance with EU Directives, Good Clinical Practice and Good Manufacturing Practice
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.
Pharmaceutical development and manufacturing
- ensuring that new products are developed on-time, on-budget and in compliance with the latest regulatory standards.
Our clients range from small start-ups to multinationals and are located around the world. We can free up your management resource and add value to your research and development activities while ensuring that data generated will comply with recognised standards of Good Clinical Practice and Good Manufacturing Practice.
- technical assessments of acquisition or in-licensing opportunities
- compiling dossiers for presentation to potential out-licensing partners
- providing expert evidence to support legal actions