With the introduction of new technologies, both the development and life-cycle maintenance activities of many biopharmaceutical and novel chemical entity products require a strong understanding of the science. Although important, merely knowing the guidelines in not enough.
BioVentures Consulting Limited recognises the importance of understanding the science and the technical issues
Devising a robust development strategy also needs to include a combination of experience with a detailed understanding of the science behind the product. The reason BioVentures Consulting Limited has adopted its strap line ‘’the application of strong scientific understanding’’ is that we recognise the importance of understanding the science and the technical issues behind a development programme is essential for the successful licensing and positioning of a product.
Regulatory requirements need to take the science into account. Only through this approach can concrete arguments and a robust dossier be developed. BioVentures Consulting Limited is able to apply critical scientific rigour to the development of your regulatory strategy.
These days most development programmes are unique, and regulatory requirements need to be applied on a case-by-case basis.
We have worked on some of the most technically demanding projects in the Industry
Indeed, understanding the science is a key aspect of knowing what regulatory requirements need to be applied.
BioVentures Consulting Limited has even worked with regulatory agencies to develop new regulatory requirements for future adaptation by Industry, in response to the introduction of new technologies.
BioVentures Consulting Limited has worked on some of the most technically demanding projects in the industry. Successful assignments have included our involvement in leading gene therapy, vaccine, antibody and therapeutic protein programmes, as well as those involving novel oncology biomarkers. BioVentures Consulting Limited can advise on the regulatory requirements of our client’s development programme and identify existing data gaps which need to be filled prior to submission, or in response to Agency questions, including deriving agreements on post-approval commitments.
BioVentures Consulting Limited can liaise with regulatory agencies, organise and facilitate meetings (including agency hearings and preparation of briefing documents) with regulators with the aim of seeking endorsement for a product development strategy.