Having reached this stage your chances of reaching the market
with your discovery compound have increased by a factor of
forty*. (*Reference 1)
Still only 1 in 250 compounds will make it. Acting on advice
from your Regulatory Partner will increase your chances of
success*. (*Reference 2)
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 require regulatory experts who understand the PK
and PD of biotech and biologic products?
Using a pragmatic
approach and good arguments, we could help you satisfy the
regulators with a more streamlined non-clinical programme.
