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.
Founder and Principal Consultant