BioVentures Consulting Limited provides regulatory affairs advice on US and EU filing strategies at all stages of product development. We can work in partnership with clients throughout the development process, from discovery and proof of concept stage, through clinical product development, regulatory submission and dossier approval for a marketing authorisation; for both biopharmaceuticals and chemical entities.
Regulatory approval strategy should be considered early in the product development process
Filing strategy may include a determination of whether a European dossier should be filed via a national procedure, or via the mutual recognition/decentralized or centralized procedure.
The regulatory approval strategy should be considered early in the product development process, although BioVentures Consulting Limited can help by providing regulatory guidance at any stage of project development. BioVentures Consulting Limited strategic guidance can be either hands-on via a long-term interim management arrangement or as a sounding board (the so called ‘will it pass the red face test’’) via a short-term consultancy. Our input often leads to a more robust development and submission plan, and well-considered options for filing strategies.