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YOUR PARTNER
for a full Regulatory Affairs Service |
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Non Clinical Trials
 At
this stage you will be required to carry out intensive in
vitro testing generally coupled with studies in species.
If you are unsure about any component of the 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:
• As your independent regulatory contractor we
can:
• Review and advise on your non clinical program
• Recommend contract houses for your pre-clinical
studies
• Recommend opinion leaders in your field
• GLP compliance mock inspection
• Prepare your CTD Module 4 and write your non
clinical overview and summary.
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Is one study enough to obtain the necessary PK, PD, toxicity
and immunogenicity data?
Have you considered immunological properties to design your
proof-of-concept studies?
Have you considered species specificity and other factors
prior to your studies?
Do you need to assess toxicokinetics and recovery?
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Using a pragmatic
approach and good arguments, we can help you satisfy the Regulators
with a streamlined non-clinical program. |
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