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Claire Waters BPharm PGDip MTOPRA

Director

Claire is a pharmacist with extensive hands on experience of drug usage through clinical pharmacy practice.  After graduation and pre-registration training at St Georges Hospital, London Claire worked in a variety of pharmacy roles and was a sitting member of the Essex Local Pharmaceutical Committee.  Claire moved into regulatory affairs in 2014 as an employee at Regulis Consulting undertaking lifecycle management and supporting Marketing Authorisation applications across a range of therapeutic areas. Claire has acted as in-house Quality Assurance Deputy supporting preparation and  successful outcomes for both an MHRA PV and GDP audits.  Since founding Theraproval in 2018 Claire has provided regulatory consulting services to pharmaceutical and medical device companies, developing oncology, neurology (including pain) and ophthalmology products.

Claire attained her Bachelor of Pharmacy from The School of Pharmacy University of London.  Claire also holds a Post diploma in Community Pharmaceutical Healthcare from the University of Brighton and has also completed proof reading training and is member of The Organisation for Professionals in Regulatory Affairs.

 

Robert Waters BPharm PhD

Consultant

Robert is a pharmacist with 20 years of regulatory experience gained in small to large pharmaceutical companies including Bausch & Lomb, Allergan and Astellas.  In addition to his primary interest of late stage clinical development and license negotiation Robert has extensive experience in CMC (particularly sterile manufacture), lifecycle management and clinical trials operations management.  Over his career Robert has led successful MAA's, PIPs, orphan drugs and led numerous agency interactions in ophthalmology, urology, neurology and oncology. 

Robert attained his Bachelor of Pharmacy and PhD in analytical chemistry from The School of Pharmacy University of London. 

 

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Next Steps...

Please call, use the contact form or email us direct to discuss your requirements:

claire@theraproval.com

+44 (0)789 067 3387

 

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