About Us
We are a London-based pharma and biotech consultancy dedicated to providing expert strategic and technical guidance to clients facing the complexities of global regulatory pathways. With an in-depth understanding of the evolving regulatory landscape, we specialise in helping organisations navigate the multifaceted challenges that arise as they scale their pharmaceutical development internationally.
​
In today’s interconnected world, organisations must address a growing array of regulatory requirements across diverse jurisdictions. Our team of experienced professionals offers a unique combination of technical expertise and strategic insight, helping clients not only meet regulatory requirements, but also optimise their development plans to address unmet medical needs.
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)
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
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
Contact Us
Experts specialising in global regulatory affairs
128 City Road London
EC1V 2NX
UNITED KINGDOM
+44 20 8933 1806
