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's a common misconception that "you only need regulatory
affairs when your Research and Development is complete". This couldn't
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 include:
• Honest regulatory advice
• Recommendation of experts in your field
• Recommendation of contract houses for subsequent
development, e.g. ADME
• Orphan Drug Designation advice
Do you fully understand
the regulatory framework in which you need to work?
Are you aware of the latest guidelines relevant
to your product and its therapeutic area?
What does CTD
(Common Technical Document) mean to you?
Taking
early advice on your development programme
means early to market. The key to success
is to plan and spend money on studies wisely.
If your product is for a rare disease, it may be eligible
for Orphan Drug Designation. Let us inform you of the commercial
advantages.
Only 1
out of 10,000 lead compounds make it to the market*.
Make sure yours is the successful one. (*Reference 1)
Taking
early advice on your development programme
means early to market. The key to success
is to plan and spend money on studies wisely. 
