Welcome to Highbury Regulatory Science

About Us

Our history

Bob Clay established his own regulatory cons​ultancy practice through Highbury Regulatory Science in 2014.  Prior to this he was VP Global Regulatory Affairs at AstraZeneca with responsibility for oncology, infection and personalised healthcare. He is a regulatory strategist with more than 30 years' experience in drug development. 

Our mission

Highbury Regulatory Science provides consulting support to small and m​id-size growing biotech companies on regulatory and development strategies across a range of therapy areas and regions.  We support programmes in new drug development, devices and diagnostics.  We also provide management consultancy and board advisory services on organisational development and outsourcing key regulatory activities.​​​​ 

We are global

We have offices in London, Manchester and Dublin - but work with companies across the world - see Locations

Latest News

Conferences

Bob Clay represented APSGB at the Parliamentary Links Day 2019  organised by the Royal Society of Biology


Bob participated in the TOPRA Summit in London on May 23rd 2019


Bob Clay was a presenter and panelist at an event organised by Hyper Recruitment Solutions - HRS on "Quality and Regulatory Considerations  for UK Pharma/Biotech


Bob Clay chaired the recent TOPRA CRED Navigating European Regulatory Procedures 22-23 March 2018, Utrecht 


Bob Clay presented on  "Novel clinical trial design and technology impact on regulatory advice and shape development of new medicines" at the Adaptive Designs in Clinical Trials meeting presented by SMi in London on April 9-10th 2018


TOPRA delivered training programmes at the Malta Medicines Authority in March for regulatory professionals.  Bob Clay led several sessions on the one-day "Essentials" and two-day "Introductory" courses.



Publications

Check out our papers and conference presentations on our News page


Recent client success

During 2017, two clients received positive CHMP Opinions - we provided support to the submission development and responses to questions raised during review.


Following our preparation and support for a pre-IND meeting, our UK-based client successfully opened their first IND.  We have supported continued interactions with FDA moving towards end of Phase 2 meeting in 2019


A US-based start-up recently opened first IND and gained an orphan designation with our support.


We have supported clients in three other pre-IND meetings in different therapeutic areas at FDA during 2016-7.   


Another client successfully completed an FDA end of phase 2 meeting and plans to initiate Phase 3 studies in the second half of 2018.


Talk to us about the role of regulatory meetings in your development programme.  Since 2017,  we have managed IND amendments and following completion of the phase 1 study supported the design and submission of a phase 2 study to the IND.

Contact Us

Let's see if we can help

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Highbury Regulatory Science

108 Eaststand Apartments, Highbury Stadium Square, London N5 1FF, United Kingdom