From building teams to delivering key milestones, our partners bring many years of hands-on global regulatory strategy and CMC leadership experience, providing a highly functional partner to our clients and enabling us to meet your organisation’s goals.

We take a tailored approach to navigating the end-to-end regulatory paradigm with depth of experience in:

• Preparing and leading regulatory meetings including pre-CTA/IND, INTERACT and Innovation Office

• Securing designations and accelerated development pathways including Fast Track, Breakthrough, Orphan, RMAT and PRIME

• Clinical Trial Strategy including initial CTA and IND applications and compilation of IMPD/Module 3

• Marketing Authorisation and Biologics License Applications

• Investment due diligence and ‘Technology to Spin-Out’ input

Leverage our expert team and global network to pressure test your regulatory strategies and challenges.

We can contribute to your own Regulatory Advisory Board or lead it’s formation, hand-selecting the relevant consultants, delivering pre-read materials and coordinating relevant feedback.

Both solutions aim to ensure your strategy is robust and designed to meet regulatory expectations.