Regulatory Due Diligence: Assessment of Pharma and CHC Product Portfolios
A well-founded valuation of medicinal products, medical devices, and related products requires transparency regarding marketability and compliance risks. Diapharm analyzes the current regulatory status and the underlying documentation of products and portfolios. In addition, Diapharm assesses the strategic potential with regard to positioning, internationalization, and commercialization to specifically identify investment opportunities.
From a regulatory perspective, Diapharm reviews:
- Completeness and currency of:
- Marketing authorization documentation (medicinal products)
- Technical documentation (medical devices)
- Product information files (cosmetics)
- Food law documentation (food supplements)
- Status of any pending procedures (applications, variations, conformity assessments, etc.)
- Status of clinical documentation as well as clinical trials, studies, or assessments
- Quality management (GMP, ISO 13485, HACCP) and vigilance
- Regulatory evaluation in relation to the further product lifecycle
Value and potential assessment
Beyond regulatory due diligence, Diapharm also undertakes the assessment of market potential for medicinal products, medical devices, dietary supplements, and cosmetics, with respect to:
- Market value (based on regulatory substance, market environment, development timelines, etc.)
- Reproducibility (effort required for redevelopment and/or re-categorization into an alternative product class)
- Growth opportunities
