Confidence Beyond Compliance

Whether acquiring a single pharmaceutical product or an entire portfolio, you want to be certain that the acquisition ultimately satisfies your business needs and expectations. Our experts can assist in assessing the value of the license opportunity and identifying critical regulatory and development issues that otherwise could come to light after the purchase.

Our experts combine longstanding international regulatory affairs and scientific expertise in a wide range of therapeutic areas for human and veterinary pharmaceutical products (NCEs, NBEs, ATMPs, biosimilars and generics, herbals, medical devices and drug-device combinations).

At PharmaLex, we have established a reliable, systematic and thorough 4-step approach as the key to a successful Due Diligence:

  1. Preparation
    • Understanding the clients’ needs and scope of the Due Diligence
    • Appointing the PharmaLex Due Diligence Team
    • Preparing project-specific check lists
  2. Information Gathering
    • On-site review
    • Data room review
    • Questionnaire to licensee
    • Interviewing licensee
    • Selecting corresponding scientific regulatory and legal framework
  3. Analysis
    • Identifying gaps, deficiencies, post-approval obligations
    • Assessing risks & regulatory impact
    • Identifying upside potentials (e.g. other indications and / or populations)
    • Evaluating time & cost implications
  4. Reporting
    • Flagging deal-breakers, major and minor findings
    • Recommending how to resolve issues
    • Proposing follow-up actions and next steps
    • Indicating upside potentials