Meeting Regulatory Agencies is an important part of the development and licensure process. This is due to the long and costly development process for new pharmaceuticals with huge commercial pressure on companies to secure marketing authorisations in the shortest time. It is therefore of critical importance that all of the regulations governing the development, manufacture, and registration are followed to ensure success.
Regulatory Agencies permit and encourage early engagement between technical and scientific companies and 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 / major regions are:
How Woodley BioReg can help?
Woodley BioReg provides a full range of services to support pharmaceuticals, biopharmaceuticals, healthcare, over-the-counter products and medical devices from the development of registration strategies to the preparation and submission or registrations documents in eCTD format. To prepare your registration file we support you through a range of services including:
• Discussing the options for registration
• Arranging agency meetings and providing briefing documents in line with regulatory requirements
• Assisting you in preparing your meeting presentations, including key decisions
• Participating in Regulatory Agency Meetings and supporting your position 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.
Once registered WBR also provide a full range of services during product lifecycle maintenance activities including:-
• Agreeing submission strategies e.g. Abridging Applications, Orphan Designations
• Addressing Regulatory Agency questions / Requests for Information (RFI)
Please contact us for more information on Regulatory Agencies and the help we can offer.