Somerset House Consultants - Quality Compliance, Outsourcing, Supply Chain and Auditing Solutions

Somerset House Consultants designs and implements quality compliance systems and outsourcing solutions for emerging and virtual pharmaceutical companies. Founded in the UK in 2001, our international client base now covers Europe, the US, Japan, Australia, India and China.

We have wide experience in good manufacturing practice, quality risk management, supply chain traceability, correcting regulatory inspection deficiencies and 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, high-potency and herbal products. Our consultants are EU Qualified Persons and ISO-qualified lead auditors.

All our services comply with internationally recognised standards of good clinical practice and good manufacturing practice.

GMP-compliant quality management systems

Somerset House Consultants has long experience in designing GMP-compliant quality management systems for active pharmaceutical ingredient, investigational medicinal product and marketed product manufacturers. We audit suppliers worldwide for compliance with EU, FDA and ICH requirements and provide Qualified Persons to certify batches in accordance with EU directives.

Qualified person batch certification

Somerset House Consultants provides experienced contract Qualified Persons to carry out EU batch certification of investigational medicinal products and marketed products on a temporary or permanent basis. Our expertise covers sterile and non-sterile dosage forms, small molecules, biotechnology and herbal products.

Assistance with regulatory authority inspections

Somerset House Consultants carries out mock audits and staff training to allow companies to prepare for EU and FDA inspections. We assist companies to prepare and manage corrective action plans to address inspection deficiencies and ensure successful reinspection.

Supply train traceability and GMP audits

Our ISO9001-qualified auditors carry out Good Manufacturing Practice compliance audits of active pharmaceutical ingredient, investigational medicinal product, excipient, packaging material and marketed product manufacturers worldwide, including:

• Supply chain traceability
• Supplier and contractor audits
• Audits of companies wishing to import products into the EU
• Pre-audits in preparation for competent authority (e.g. EMA, MHRA, FDA) inspections
• Design and management of corrective action plans

Audits are carried out in accordance with FDA or EU GMP, ICH Q7, ISO9001:2008 and IPEC standards.

Quality risk management programmes

Somerset House Consultants sets up quality risk management programmes and carries out risk assessments to meet ICH Q9/EU Annex 20 requirements, including:

• Risk assessment
• Risk control
• Risk review
• Risk registers

CMC development

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

Investigational medicinal products

Somerset House Consultants has wide experience in manufacturing and dispatch of investigational medicinal products for clinical trials worldwide - from small bioavailability studies through to multinational Phase III trials. We propose and manage solutions specific to particular trials, or work with your existing manufacturers to ensure that the supplies comply with legal requirements.

We support your trial from initial planning through to the final report, including:

• Good Clinical Practice and Good Manufacturing Practice compliance
• Qualified Person release for clinical trial supplies
• Selection and auditing of manufacturers
• Setting up technical agreements with manufacturers
• Product specification files
• QP declarations for non-EU manufacturing sites