Email: enquiries@bioventurescl.com

Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

About BioVentures Consulting Limited

"The Application of Scientific Expertise to Regulatory Affairs Matters"

BioVentures Consulting Limited offers regulatory and product development expertise to the pharma, medtech and biotech industries. Services include project management, EU or US approval strategy, new product development, due diligence, technical dossier compilation, consulting, post-approval maintenance and regulatory publishing services.

BioVentures Consulting Limited was formed in 2002 by Stephen Rees, a consultant now with 22 years industry experience in regulatory R&D disciplines, including toxicology, pre-clinical development, clinical pharmacology, late-phase clinical development, regulatory and CMC (including biological manufacturing).

Stephen Rees has worked on some of the most technically demanding development projects in the industry, including pioneering gene therapy, antibody, vaccine and therapeutic protein programmes; as well as life-cycle management projects with highly complex product histories and interwoven global strategies. As such Stephen specializes in progressing high-value projects which require strong scientific and technical understanding, and in delivering the life-cycle management strategy (including post-license maintenance and variation work) for established products.

Thus, BioVentures Consulting Limited offers a full Regulatory Affairs and Regulatory Operations service, which to date has an outstanding track record of delivering successful development and life-cycle management projects to its clients.

How BioVentures Consulting Limited works with you

BioVentures Consulting Limited engages directly with clients and offers the services of Stephen Rees, or agreed associates, on an interim contract or consultancy basis, through a combination of both off-site and on-site delivery. Stephen believes flexibility is an important attribute in the modern services industry and hence offers a personalized and tailored approach which best meets individual clients’ needs.

A transparent and clear brief if developed which ensures project deliverables are completed to high quality, on time and within budget, and that expectations are met in full. Assignments have ranged from 2 days (sketching out a product development route) to 5 years (taking a product from End of Phase II to product Approval and line extension planning).

Stephen Rees also works alongside a ‘tried and tested’ team of consultants, each experts in their own disciplines, who are also personal friends (believing that people who like working together can form the most effective teams!) BioVentures Consulting regulatory operations and publishing output is delivered by working alongside Mark Willoughby via an established agreed alliance relationship.

BioVentures Consulting Limited offers a full Regulatory Affairs and Regulatory Operations service, which to date has an outstanding track record of delivering successful development and life-cycle management projects.

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