CambReg: Cambridge Regulatory Services: Your Partner for a full Regulatory Affairs Service

YOUR PARTNER
for a full Regulatory Affairs Service

CambReg: Your Partner for a full Regulatory Affairs Service

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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?

 

NCE: Non Clinical

 

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

Working with:UK Trade & Investment Investor in People
CambReg: Your Partner for a full Regulatory Affairs Service
© Cambridge Regulatory Services 2007
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