ProTherax Ltd was founded in 2011 after 20 years experience working in pre- and post marketing regulatory affairs, medical and technical writing and senior management positions across a range of life science sectors, but particularly within biotechnology and pharmaceuticals.

I continue to act as ProTherax’s Principal Consultant, and consequently I am intimately involved in managing all projects the company undertakes. Since we began trading in June 2011, we have undertaken a range of project sizes including:

• Preparation of Clinical Study Reports (Phase I, II and III), Clinical Evaluation Reports & Clinical Reviews

• Regulatory Scientific Advice Procedures
• Clinical Trial Applications and US INDs
• Developmental Safety Update Reports
• Strategic Advice and preparation of development plans and clinical protocols
• Marketing Authorisation reviews for Regulatory Compliance
• Post-Marketing Variations Type IA, IB and II
• Regulatory training

As a small business however, I recognise that to achieve larger projects on time and on budget, additional resource or expertise may be needed. In these situations, I can draw on a network of experienced consultants, with a variety of backgrounds and from across the globe, to help support your project.

Having roots in biotechnology and start-up (venture funded) companies, I recognise the need to ensure that our solutions are cost-effective for the client. To achieve this, we offer a flexible range of rates from hourly through to fixed cost projects, matched to the size of your project.

Please feel free to contact us today for a no-obligation quotation.

David Fairlamb
Founder and Principal Consultant

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