ESPL Regulatory Consulting

Scientific Advice, Strategy and Specialist Applications

ESPL works with both SMEs and big Pharma on regulatory strategy and advice from regulatory agencies for a wide range of different therapeutic areas.
We also support our clients with PRIME, PIP, Orphan, ATMP and drug-device applications.

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.

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