It
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.
