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.

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