Regulatory due diligence: pharma and CHC product portfolio reviews

The due diligence of investment decisions in the highly regulated pharmaceutical and healthcare industry requires a special field of analysis: regulatory due diligence. Transparency with regard to marketability and potential compliance risks throughout a product’s life cycle is the key to finding a prudent purchase price for medicinal products, medical devices and related goods.

Regulatory due diligence therefore expands the financial, legal and commercial diligence in order to include a review of a product portfolio’s regulatory status as well as opportunities from a regulatory and strategic perspective.

Diapharm analyses the regulatory status of medicinal and healthcare products as well as entire product portfolios on behalf of clients such as auditors, law firms and investors. We determine whether products are truly marketable in terms of regulation and whether their documentation and basis of data reflect the latest scientific findings.

In addition, we review the strategic potential of the products and markets that could be viable options with regard to new opportunities for claims, internationalisation and much more.

On request, we support our clients beyond the regulatory due diligence process to help determine the market value and potential of medicinal products, medical devices, food supplements, cosmetics and entire product portfolios with regard to the following aspects:

• Market value (based on regulatory recoverability, uniqueness, market environment, time to market, etc.)
• Reproducibility (effort and expense for new development and/or implementation in an alternative product category)
• Opportunities for international growth
• Opportunities for domestic growth (cf. product and portfolio strategy)

• Ensuring complete and up-to-date
  • Marketing authorisation documents (medicinal products)
  • Technical documentation (medical devices)
  • Product information files (cosmetics)
  • Documents required under food law (food supplements)
• Status of ongoing procedures (applications, variations, conformity assessments, etc.)
• Status of clinical documentation and, where applicable, any ongoing clinical studies, tests or evaluations
• Quality management (GMP/GDP, ISO 13485, HACCP) and vigilance
• Regulatory evaluation with regard to the further life cycle