The long and costly development process for the development of new pharmaceuticals places huge commercial pressures on companies to secure Marketing Authorisations in the shortest time.
Regulatory agency meetings play an important part in responding to agency concerns and developing a consensus for the development and registration process. Effective agency interactions, communication, and management are critical to the timely success of product approval.
Regulatory agencies permit and encourage early engagement between technical and scientific companies, assessors, and reviewers to ensure any formal submissions for either clinical trials or product licensure are reviewed and approved expeditiously. This involves discussion and negotiations, to ensure regulations are interpreted and applied in line with expectations.
Three regulatory agencies for the larger markets and major regions are:
Need further information?
Woodley BioReg provides a full range of services to support pharmaceuticals, biopharmaceuticals, healthcare, OTC products, and medical devices from the development of registration strategies to the preparation and submission of registrations documents in eCTD format.
WBR prepares and support clients through a range of services including:
- Discussing the options for registration
- Arranging agency meetings and providing briefing documents in line with regulatory requirements
- Assisting in the preparation of meeting presentations, including key decisions
- Participating in regulatory agency meetings and supporting client positions through sound and scientific argument
- Ensuring compliance to the relevant regulations
- Ensuring post-meeting notes are accurate and complete and that any actions are assigned
- Following up with regulatory agencies to ensure any actions are completed
WBR’s experience in managing and navigating meetings with regulatory bodies globally is underpinned by our expert knowledge in science, regulatory affairs, and quality risk management.
Our most frequent agency meetings include:
- IND meetings – pre-IND, EOP meetings
- Scientific advice meetings
- Orphan designation meetings
- Pre-submission meetings (MAA and BLA)