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Services

A London-based consultancy providing strategic and technical regulatory expertise to help you

address the uncertainty in your global  clinical development and market authorisation plans

International Reach

  • Africa (Sub-Saharan)

  • Central and Southern Asia

  • Eastern Asia

  • Europe and UK

  • Latin America and the Caribbean

  • Middle East and Northern Africa

  • North America (US & Canada)

  • Oceania (Australia & New Zealand)

REGULATORY STRATEGY

Clinical Trial Applications & INDs
Health Authority Meetings

Market Authorisation Applications

TECHNICAL EXPERTISE

Nonclinical & Translational Science
CMC (Module 3 & IMPD)
Good Manufacturing Practices
Medical Devices & Diagnostics

MEDICAL

WRITING

Standard Operating Procedures
Regulatory Designation Requests
Briefing Books
Applications
Annual Reports

DUE

DILIGENCE

Mergers & Acquisitions
Business Development
Partnerships

Specialties and Product Types

Biosimilars
Small Molecules
GMOs
Diagnostics
Biologics
Medical Devices
Advanced Therapies
Combination Products
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