East Kent Pharma Consulting Ltd
WHO WE ARE
We provide expert consultancy concerning the pre-clinical regulatory file of pharmaceutical products. Our particular expertise is in supporting the safety rationale for product specifications (impurities, excipients, leachables and extractables, heavy metals, etc). If you are wondering whether a new impurity is qualified or how a manufacturing change should best be supported, we can help you.
We also have expertise in supporting the entire safety file for older or legacy products which may have undergone many changes since they were initially developed. If you need advice on how to contemporise an old safety file (pharmacology, toxicology etc) to current ICH CTD standards, or how to repurpose an old file for a new product (such as a generic), then we can help you!
OUR EXPERIENCE
Andrew Fleetwood, the company Director, has over 20 years experience with a major international pharma company
and prior to that, with the UK Government. He is a UK-registered veterinary surgeon and a chartered biologist, with specialist training in toxicology and veterinary clinical pathology.
Andrew has been responsible for the non-clinical section of the regulatory file for a number of human pharmaceutical products, and provided toxicological leadership to the specification setting process for products in development and in the commercial phase.
Andrew has also served as company representative to the EFPIA Preclinical Development Committee.
Andrew is author of a number of publications in the safety and pathology fields and has been a speaker at a number of international symposia.
Contact Us
To get in touch
Registered Address: Highfield Stables, Stoneheap Road, East Studdal, Dover CT15 5BU United Kingdom
