|
|
|
|
|
|
Regulatory Support...
Popular
with our clients, PBC’s expert literature reviews and regulatory
documents explain and substantiate a product’s science, rationale,
safety and clinical data in ways that gain the respect of
regulators. This is particularly important in the preclinical
packaging of new biological technologies where the clarity of a
sponsor’s scientific arguments and supporting data can impact the start
of a clinical trial, and even product approval. Regenerative
medicine, tissue engineering and cell-based therapies are a specialty.
Quality scientific and clinical publications are also invaluable in
creating the proper perception of a new technology or product in the
marketplace.
Need data?
Parenteau BioConsultants can support your development of supporting
data...
As former
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. Now, we can help you do the same.
|
|
|
|
