Email: enquiries@bioventurescl.com

Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Biotechnology filing

The development of biopharmaceutical medicines follows the same principles as for new chemical entities, although in general biotechnology products are often more complicated than chemical medicines.

"Our expertise in biopharmaceuticals development is what gave us our name - BioVentures Consulting Limited"

BioVentures Consulting Limited has particular expertise in the development and approval of biopharmaceuticals marketing authorizations or Biologics License Applications (BLAs) for biological products. Indeed, our expertise in Biopharmaceuticals development is what gave us our name "BioVentures Consulting Limited" recognising both the complexity of biological drug development, and the adventure/excitement these programmes can bring – at least for those of us who enjoy grappling with, and solving, the nature of the issues involved!!

BioVentures Consulting Limited has direct experience and expertise in the successful development and approval of vaccines, antibodies, therapeutic proteins and gene therapy programmes. We are familiar with the significant regulatory hurdles involved and know how to jump them. The Council regulation 2309/93, as amended recognises biotech products as requiring expert review, where it is mandatory to progress such products in the EU through the Centralised applications procedure process. BioVentures Consulting Limited can advise on which regulatory Agencies may have the right therapeutic area of expertise, or biotechnology drug manufacture know-how. Our expertise with these matters becomes more important now that companies cannot input into the selection of the Rapporteur. In this regard BioVentures Consulting Limited can be an ideal partner to help with the filing and approval process of your Biopharmaceutical product.

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