Somerset House Consultants

Somerset House Consultants has long experience of design and management of pharmaceutical development, manufacturing, and quality assurance programmes.

GMP Compliance Consultants

Founded in the UK in 2001, we have an international client base covering Europe, US, Japan, Australia and India. We are flexible and responsive to meet your specific needs.

Our GMP compliance consultancy services include:

• Setting up GMP-compliant Quality Assurance systems
• Qualified Person release
• Supplier audits
• Interim management
• Staff training

We have particular experience in handling active pharmaceutical ingredient (API) audits and Qualified Person release of investigational medicinal products (IMP).

Active Pharmaceutical Ingredients

Somerset House Consultants has long experience in the manufacture of Active Pharmaceutical Ingredients in accordance with the ICH Q7 Good Manufacturing Practice guideline. We regularly audit drug substance manufacturers worldwide.

Our API services include:

• Selection and management of contract manufacturers
• Supplier audits
• Generation of Quality Agreements

GMP-Compliant Quality Assurance Systems

Somerset House Consultants helps companies to set up GMP-compliant quality assurance systems that are appropriate to their needs.  We provide a range of services to ensure that you and your contractors meet EU and FDA Good Manufacturing Practice requirements, including:

• Preparation of Standard Operating Procedures
• Preparation of Validation Master Plans
• Preparation of Site Master Files
• Staff training
• Dealing with regulatory authorities
• CAPA
• Technical/Quality Agreements

Our expertise covers Active Pharmaceutical Ingredients, Investigational Medicinal Products, sterile and non-sterile dosage forms and biotechnology products.

Good Manufacturing Practice Compliance Audits

Somerset House Consultants carries out Good Manufacturing Practice compliance audits for Active Pharmaceutical Ingredients, Investigational Medicinal Products and marketed products, including:

• Supplier and contractor audits
• Audits of companies wishing to import products into the EU
• Pre-audits in preparation for competent authority (eg EMEA, MHRA, FDA) inspections
• Design and management of corrective action plans

Investigational Medicinal Products

Somerset House Consultants has wide experience in manufacturing and despatch 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:

• Ensuring compliance with Good Clinical Practice and Good Manufacturing Practice
• Qualified Person release for clinical trial supplies
• Selection and auditing of manufacturers
• Setting up Technical Agreements with manufacturers
• Maintaining Product Specification Files

Pharmaceutical Virtual Quality Management™

Our Virtual Quality Management™ product is specifically designed to help pharmaceutical companies comply with regulatory requirements.  A dedicated quality professional works directly for you on a part-time basis to provide a cost-effective solution.

Amongst the tasks carried out by this quality assurance specialist are:

• Setting up quality systems and Standard Operating Procedures
• Auditing CRO’s and Investigational Medicinal Product manufacturers for compliance with GCP and GMP
• Releasing supplies
• Drawing up Technical Agreements with each contractor
• Good Manufacturing Practice documentation reviews
• Ongoing project reviews and problem solving

Interim Management

One of our experienced professionals can work in your company to cover short to medium-term workload peaks or specific projects.

Contact:

Robert Haslam
Somerset House Consultants
Somerset House
Ball Road
Pewsey
Wilts SN9 5BN
UK

Tel: +44 1672 562225
Fax: +44 1672 564532