Regulatory submission requirements
BioVentures Consulting Limited understands the environment in which new medicines are developed. BioVentures Consulting Limited has expertise in all aspects of the process for new product development from discovery to life-cycle management, and the importance of regulatory affairs in this process.
"BioVentures Consulting Limited can advise on the regulatory submission requirements"
BioVentures Consulting Limited can develop your new product development programme in the context of the European Pharmaceutical Legislation and the Legal Framework and has expertise in all the main European procedure types including Centralised, Mutual Recognition and Decentralised Procedures.
BioVentures Consulting Limited can advise on the regulatory submission requirements of many therapeutic areas, including neurology, oncology, infectious diseases, gastroenterology, cardiology and life-style therapies (including obesity and women’s sexual health), and at all stages of development – from discovery to first-in-man trials, to late-stage development, submission, approval and life-cycle maintenance and line extensions.
BioVentures Consulting Limited is also familiar with the regulatory submission requirements of both biological entities and small molecules (chemical entities), having been involved with gene therapy, vaccine, antibodies and therapeutic proteins. BioVentures Consulting Limited has experience of both US and European drug development programmes. It has successfully progressed two successful BLA’s through the US FDA to approval.