Protherax

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.Read More