Harefield Pharma Associates is a consultancy specialising in regulatory and clinical affairs to assist both large and small companies both in the UK and overseas. The Directors of the Company are Larry Glick and Dr. Chris Speirs.

The principals have wide ranging regulatory, clinical and product development experience gained from a variety of organisations. In addition, a number of supporting consultants in areas such as statistics, pharmacokinetics, formulation design etc. are available.

Areas of Expertise

• Advice on all aspects of drug regulatory affairs
• Assessment of data requirements
• Registration dossier compilation for all markets
• Assistance on all aspects of the medical device directive
• CTX and CTC preparation
• Preparation of pharmaceutical, toxicological and clinical expert reports
• Preparation of Drug Master Files
• Design and monitoring of clinical studies
• Liaison with regulatory bodies and management of appeals
• Formulation development
• Drug development project planning and management
• Preparation of patient information leaflets, SPC documents & labelling
• Advice on compliance with regulations for promotion of medicines

Harefield Pharma Associates are pleased to provide services on an hourly, project or contract basis.

For further information and a free of charge quotation, please contact Larry Glick at the following address:-

Elite House,
Hill Farm Industrial Estate,
Leavesden,
Watford,
Herts.
WD25 7SA,

Tel: 01923 686 643
Fax: 01923 681 221
e-mail: hfpharma@aol.com