So you've made an exciting discovery of a potential new
drug!
You've identified your drug candidate and carried out pharmacology
studies to support its development into a therapeutic entity.
Now do you have the regulatory resource and experience to
turn your discovery candidate into a marketed medicine?
It is a common misconception that "you only need regulatory
affairs when your Research and Development is complete". This could not
be further from the truth because everything that you do from
this stage onwards must be done to standards that will satisfy
regulatory authorities in world markets.
Our
Services
At this
stage we can help with:
• Honest regulatory advice
• Recommendation of experts in your field
• Recommendation of contract houses for subsequent
development, e.g. ADME
• Orphan Drug Designation
Do you fully understand the
regulatory framework in which you need to work?
What does CTD (Common Technical
Document) mean to you?
"As somebody who has over 25
years' experience in pharmaceutical R&D, I found the performance
of Cambridge Regulatory Services Ltd to be a way above average
for regulatory affairs consultancies and would not hesitate
to use their services again should the opportunity arise."
J.D
ENACT
Taking early
advice on your development programme means early
to market. The key to success is to plan and spend
money on studies wisely.
