BioDesk

BioDesk is a unique global product development and regulatory planning consultancy positioned to take biotechnology companies efficiently through preclinical/CMC, allowing earlier entry into human safety & proof-of-concept clinical trials and beyond!

BioDesk has assembled an international, multi-disciplinary network of preclinical and regulatory consultants and will draw from these to select the ideal team, optimised for each project. BioDesk’s experts can also engage with clients at the earliest of stages of product profiling, market positioning and support for investor due diligence.

To find out more about our services or to request a meeting or estimate simply fill in the online form.

Mark Reid, who heads up the consultancy, has a track record as a Clinical Investigator and as a Senior Regulatory Affairs Manager in Europe and Australia, advising clients in preclinical and clinical planning for their NCEs and Biologicals. Mark is a recognised expert in virology and the regulatory environments around the world for gene therapy and genetically modified organisms (GMOs), giving BioDesk a particular advantage.

Specifically the services offered by BioDesk include:

• developing a forward looking Target Product Profile (TPP);
• supporting the development of investigational product and preclinical data to support entry into the clinic;
• formulating development plans appropriate to venture capitalists and regulators;
• strategic regulatory advice for key international and local markets;
• support and development of regulatory submissions such as INDs, CTAs, BLAs, MAAs, etc., and
• project and programme management.

Through BioDesk, CNS offers the biotech industry a focussed approach to biotherapeutic development. When coupled with Fast2First, this approach drives efficient navigation of the critical period of post-discovery planning and initial clinic testing whilst adding value to the global dossier and delivering improved commercial outcomes to our clients.