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Non-Clinical Phase

Generics: Non ClinicalIt is unlikely that you will be required to conduct aignificant 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. Maybe the impurity profile of your product is such that possible toxicological issues need to be ameliorated before submission (genotoxicity and AMES testing, qualification data etc). 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:

 

• Reviewing and advising on your non-clinical programme
• Recommending contract houses for your pre-clinical studies
• Recommending opinion leaders in your field
• Providing a GLP compliance mock inspection
• Preparing your CTD Module 4

• Writing your Module 2 overview and summary

Are you able to evaluate whether extra non-clinical studies are required and the nature of these studies?

 

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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