Clinical and Regulatory Support...
At
Parenteau BioConsultants, we use science and our concept-to-market
experience to help clients meet development challenges and provide the
answers needed to advance their products to the marketplace.
Why we focus on non-clinical data and
information
The non-clinical data package is an integral, but often inadequately
developed, part of product and regulatory success supporting:
scientific rationale, mechanism of action, human response, safety,
product design, definition, composition, bioequivalence, and even
labeling. Laboratory testing can strengthen the case for clinical
effectiveness and safety, particularly for new technologies.
Clinical research strategy is supported by
the integration of product technology with science and medicine
We assist clients in integrating the non-clinical science of their
technology and product with available scientific and medical
knowledge to support the choice of clinical target and protocol design
– reducing risk and giving the techology its best opportunity to
achieve positive clinical results.
With an
approach developed from first-hand experience
As product developers, we have used laboratory science to validate
safety, mechanism of action, and the rationale for product
design. We have developed both validated clinical and
non-clinical assays to not only support approval but also meet the need
for feasible and economical quality assurance and bioequivalence
testing
post-approval.
Clinical and
Regulatory Support 
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