Biotech & Biologic: Non-Clinical: Cambridge Regulatory Services

Non-Clinical Phase

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?

Biotech & Biologic: Non Clinical

Using a pragmatic approach and good arguments, we could help you satisfy the regulators with a more streamlined non-clinical programme.

*References
1. www.phrma.org/innovation
2. www.ingentaconnect.com/content/ben/ctmc/2001/00000001/00000005/art00002

YOUR PARTNERfor a full Regulatory Affairs Service

Non-Clinical Phase

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?

YOUR PARTNER
for a full Regulatory Affairs Service

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?