Due diligence is the thorough review and assessment of a potential asset to determine the asset’s viability (unknowns, benefits, and risks). Due diligence involves a detailed review of available data, relevant regulations, and literature to guide informed licensing decisions and negotiations. As the pharmaceutical industry reaches record numbers of acquisitions in recent years, the challenges of acquiring assets are sure to be present.
A robust due diligence process requires diverse scientific and regulatory expertise to ensure an accurate and holistic evaluation of a potential asset. Small and/or specialized clients often lack internal resources with the relevant expertise needed to evaluate all facets of a potential asset to support sound decision-making.
Nuventra can assemble a team of experts to support a due diligence assessment of the nonclinical, clinical pharmacology, and/or regulatory aspects of a potential asset. Common issues will be evaluated for the asset in relation to therapeutic area, compound class, industry guidance documents, knowledge of current FDA requirements, and experience with similar development programs.
Due Diligence Services
Our team of drug development experts can review documentation that includes, but is not limited to:
- Legacy data
- Study reports
- Study protocols
- Regulatory communications
- Development plans
- Applicable peer-reviewed literature
Nuventra will seek to uncover issues or areas of concern regarding past data/results or the potential future viability of the asset under evaluation to inform acquisition decisions and potential negotiations.