Regulatory Support...

PBC offers a wide range of medical device and diagnostic regulatory consulting services including:
  • Regulatory strategy development
  • Training
  • Procedure and policy development and improvement
  • FDA pre-market submissions, e.g., 510(k)'s and PMA's
  • Global product registrations, dossiers and Technical File development
  • Advertising and promotional review and advice
  • Regulatory quality and clinical compliance assessment and auditing
  • Acquisition regulatory, quality and clinical due diligence
Additionally, 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 facilitate your development of supporting data.
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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.                        




Scientific due
                                                diligence for biologics  biotechnology
                                                consulting specializing
                                                in advanced biologics
                                                and cell-based therapy  life science
                                                management consultants