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 Clinical and Regulatory Services