ESPL has significant experience in other regulatory activities that fall outside Clinical / MAA / NDA procedures. These include,
- Coordinating, preparing, attending and supporting clients with Scientific Advice and Regulatory meetings; preparation briefing documents, slides, position papers and other associated documentation
- Liaising with regulatory agencies on aspects of new or existing pharmaceutical registrations, including:
o Orphan Designation applications,
o PIP (Paediatric Investigational Plan) applications,
o PRIME applications,
o SME applications,
o US QIPD applications,
- Liaising with regulatory agencies for new or existing medical devices, including
o Development of the Essential Principles / Essential Requirements checklists,
o Planning, drafting and supporting Clinical Trial Notifications
o Providing framework support for ISO 13485 Quality Management System certification
o Planning, drafting and submissions support for CE marking
- Preparing and managing applications for wholesale distribution (WDAs) or manufacturers licences (MIAs) for IMPs and drug products.
- Developing regulatory strategy to optimise regulatory processes, using the wealth of regulatory experience within the team, including (but not limited to):
o development programmes for different types of medicinal products and medical devices, and
o core value dossiers (CVDs) to support pricing and reimbursement.
For more information on how ESPL can support your business, contact us via the form below, and we can arrange a consultation.