Vyvo Biosolutions can provide practical regulatory affairs advice at all stages of product development, from the early concept stage, through process and product development, up to and beyond submission of a common technical dossier for marketing authorisation application or biologics licence application. We would recommend that regulatory input be initiated early on, but we can usually help at any stage of project development. Vyvo Biosolutions can provide strategic guidance as well as practical feedback. Our input may highlight a new regulatory avenue, leading to a more efficient development plan.
Vyvo Biosolutions understands and can interpret regulatory scenarios for clients. Input during the pre-submission phase of a project can prove to be vital; strategies for interacting with regulatory agencies contribute towards achieving consensus at scientific advice and pre-submission meetings.
Some of the services we provide in this area:
- Development and review of project plans and strategy
- Interaction with, preparation and review of submissions to, regulatory bodies in the EU and FDA (via US affiliates)
- Regulatory assessment and gap analysis
- Organisation of meetings with regulatory agencies including FDA and EMEA
- Assistance in responding to FDA and regulatory agency questions