Somerset House Consultants - Pharmaceutical Development, Manufacture and Validation

Somerset House Consultants is an independent CRO specialising in design and management of pharmaceutical development, manufacturing, quality assurance, validation and regulatory affairs programmes.

We assist pharmaceutical companies worldwide to select, audit and manage sub-contractors for their outsourced development and manufacturing projects, and supply Qualified Persons (QP) for batch releases.

We have wide experience in good manufacturing practice, managing quality compliance programmes and carrying out Good Manufacturing Practice (GMP) audits of active pharmaceutical ingredient, investigational medicinal product and marketed product manufacturers. Our expertise covers the whole range of sterile and non-sterile dosage forms, including biotechnology and high-potency products.

Our clients range from small start-ups to multinationals. Our services provide you with more management time and add value to your research and development activities, while ensuring that data generated complies with internationally recognised standards of good clinical practice and good manufacturing practice.

QUALITY ASSURANCE AND QUALIFIED PERSON RELEASE

Somerset House Consultants has long experience in managing quality assurance programmes for active pharmaceutical ingredients, investigational medicinal products and marketed products. We set up GMP compliant quality systems, draft standard operating procedures and train staff. We audit suppliers worldwide for compliance with EU, ICH and FDA requirements and provide quality person’s to certify batches in accordance with EU directives.

PHARMACEUTICAL DEVELOPMENT AND MANUFACTURING

Somerset House Consultants defines and manages CMC development programmes to ensure that new products are developed on time, within budget and in compliance with regulatory standards. This includes:

• Setting up GMP compliant systems and standard operating procedures
• Batch manufacture from initial clinical trials through to full-scale commercial manufacturing
• Analytical method development and validation, raw material characterisation, finished product testing and stability testing, in compliance with EU, FDA and ICH guidelines
• New process introductions and validation
• Technology transfer
• Batch failure investigations

MANUFACTURE AND RELEASE OF CLINICAL TRIAL SUPPLIES

Somerset House Consultants manages the manufacture, packaging, testing and QP release of investigational medicinal products, ensuring that IMP’s are manufactured on time and in compliance with Good Clinical Practice (GCP) and GMP requirements. We also draft IMP regulatory dossiers and maintain product specification files in accordance with directive 2001/20/EC.

IDENTIFYING GMP DEFICIENCIES

Somerset House Consultants carries out mock GMP inspections of manufacturing sites ahead of formal regulatory authority inspections, to identify GMP deficiencies and propose actions to correct them. We assist clients to respond to GMP deficiency letters and manage appropriate corrective action plans.

We carry out investigations into batch failures and out of specification analytical results, and propose corrective and preventive action plans to prevent recurrence.

VIRTUAL QUALITY MANAGEMENT™

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

DUE DILIGENCE

• Technical assessments of acquisition or in-licensing opportunities
• Compiling dossiers for presentation to potential out-licensing partners
• Providing expert evidence to support legal actions