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

Generics: Non ClinicalIt is unlikely that you will be required to conduct non-clinical studies with your generic product as much non-clinical data on your candidate drug will already be in the public domain.  If you are developing a dosage form different to that of the originator, then it is possible some non-clinical local tolerance studies may be required.  If you are unsure about any component of your non-clinical development, the solution is to outsource. This will be a key element in getting the work done in an efficient and timely manner.

 

Our Services include:

 

• Review and advise on your non-clinical programme
• Recommend contract houses for your pre-clinical studies
• Recommend opinion leaders in your field
• Provide a GLP compliance mock inspection
• Prepare your CTD Module 4

• Write your Module 2 overview and summary

Are you able to evaluate whether extra non-clinical studies are required?

 

Will your non-clinical database be in compliance with ICH guidelines?

 

Is it worth seeking Scientific Advice from the Health Authorities before and during your non-clinical programme?

 

Let us help you assemble the optimal non-clinical data package and so avoid awkward questions and unpleasant surprises during assessment of your MAA.


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