 |
 |
YOUR PARTNER
for a full Regulatory Affairs Service |
 |
|
 
Non-Clinical Phase
Having reached this stage your chances of reaching the market
with your discovery compound have increased forty-fold*. (*Reference
1)
Still only 1 in 25 compounds will make it*. (*Reference
2) Acting on advice from your regulatory partner will
increase your chances of success.
Our
Services
As your independent regulatory contractor
we can:
• Review and advise on your
non-clinical programme
• Recommend contract houses
for your pre-clinical studies
• Recommend opinion leaders
in your field
• Arrange GLP compliance
mock inspection
• Prepare your CTD Module
4
• Write your Module 2 overview
and summary |
Would you like to know if
you are on the right track with your pharmacology and toxicology
studies?
Do you need carcinogenicity studies?
Will your non-clinical database be in compliance with ICH
guidelines?
|
Using a pragmatic
approach and good arguments, we could help you satisfy the
regulators with a less costly and streamlined non-clinical
programme. |
*References
1. www.phrma.org/innovation
2. www.ingentaconnect.com/content/ben/ctmc/2001/00000001/00000005/art00002 |
|
|
|
|
