Our
Directors
Karen James
B Pharm (Hons) M R PharmS MTOPRA Dip Reg Aff
 Karen
James, the founder director, is a pharmacist with more than
20 years' experience in Regulatory Affairs.
Her career began as a hospital pharmacist working in a variety
of London hospitals. She then joined the UK Department of Health
Medicines Division (now MHRA) where she worked on a variety
of products and projects for the next 4 years.
Her next move took her to ASTA Medica UK as Regulatory Affairs
Manager. Karen was responsible for all aspects of UK and Irish
regulatory activity and for the majority of ASTA Medica's
corporate European regulatory projects.
Karen is experienced in all mainstream activities associated
with the registration of human pharmaceuticals.
Dynamic and commercially focused, Karen has grown the company
to a size able to handle a full range of regulatory projects of any size and
complexity.
...Particular Skills:
Management of people, projects and procedures
Mike James
B Pharm PhD M R PharmS MTOPRA
 Mike
James, co-director, is a pharmacist with more than 20 years'
experience in Regulatory Affairs.
After a PhD in medicinal chemistry and post-graduate work
in the USA, Mike joined the Welsh School of Pharmacy as a
lecturer in pharmaceutical chemistry. A career move took him
to the Medicines Control Agency (now MHRA) for 11 years where
he gained wide experience in the review of all types of application.
During this time Mike reviewed more than 2000 CTX submissions
including more than 400 for biological and biotechnology products.
Prior to joining Cambridge Regulatory Services Mike worked
for a UK-based consultancy where he specialised in strategic
advice on medicines development and the preparation and management
of major submissions for biotechnology products and other
centralised applications.
Having worked on a range of products at all stages of development,
both as scientist and regulator, Mike has a unique combination
of scientific knowledge and regulatory expertise. This enables
him to undertake a detailed review of data, and to predict
and solve problems, ensuring that submissions have the best
chance of approval in the shortest possible time. Combined
with his ability to develop a sound regulatory strategy, this
makes Mike a unique asset to any regulatory project.
...Particular
Skills:
Expert in all aspects of CMC including biotechnology products
|
