Due Diligence

VCLS assists investors and helps HealthTech product developers prepare for Due Diligences by providing targeted regulatory and value proposition assessments of innovative technologies.

We help de-risk and evaluate the feasibility of registering and gaining access to specified markets, within the proposed timelines and budget. We also analyze portfolios of marketed products and anticipate changes in order to prepare for the future. Our assessment can focus on product development plans, regulatory strategy, pricing and reimbursement hurdles, considered in the light of the companies’ own characteristics.

VCLS Senior Consultants

• Evaluate the regulatory feasibility of developing and achieving commercialization of the product(s) in the target market(s)
• Position the product(s) with reference to competition
• Analyze and evaluate regulatory submission and reimbursement strategies
• Anticipate the impact of changes in the regulatory and market access environments on product portfolios
• Verify operations, resources and quality systems to ensure adequacy with applicable regulatory requirements (GMP, GLP GCP, GVP, ISO and specific national requirements)

Why conduct a regulatory and market access assessment?

Because you may not want to invest in an asset that appears promising, but:

• For which market exclusivity has been granted to a competitive product for the next 9 years, and/or that can only be approved for a small subset of the target patient population
• Which will require 3 times more patients in a Phase 3 pivotal trials than planned
• For which consultations with regulatory authorities and/or payers have uncovered major regulatory or reimbursement concerns
• Which, once approved, will not gain reimbursement without an additional large clinical study

Because you may not want to invest in a company whose portfolio:

• Has not been properly managed, which induced the expiry of marketing authorizations (except for the US, where MA doesn’t expire)
• Is manufactured by a supplier whose authorizations have been withdrawn
• Presents troubling safety signals, or has inappropriate vigilance systems
• Is based on weak efficacy/performance evidence, which may imply reimbursement delisting