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Excel in the regulated environment

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About Us

We are a London-based consultancy dedicated to providing expert strategic and technical regulatory guidance to clients facing the complexities of global expansion. With an in-depth understanding of the evolving regulatory landscape, we specialize in helping organisations navigate the multifaceted challenges that arise as they scale internationally.

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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 compliance standards but also optimise their operations for sustainable growth.

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 development 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 and Diagnostics

MEDICAL

WRITING

Standard Operating Procedures
Regulatory Designation Requests
Briefing Books
Applications
Annual Reports

DUE

DILIGENCE

Mergers & Acquisitions
Business Development
Partnerships

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We make it as simple as A-B-C

Consultants with advanced degrees and an average of 20 years of experience!

A woman-owned, minority-owned SME registered in England and Wales

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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

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