VCLS assists investors and helps healthtech product developers prepare for, the Due Diligence exercise, by providing targeted regulatory and market access assessments of innovative technologies.
We help evaluate the feasibility of registering health products and gaining access to specified markets, within the proposed timelines and budget. We also analyze portfolios of marketed products and help anticipate environmental changes. Our assessment focuses on product development plans, regulatory strategy, pricing and reimbursement hurdles, as well as on the companies’ operations.
VCLS Senior Consultants
- Evaluate the regulatory feasibility of developing and commercializing the product(s) in the target market(s)
- Position the product(s) with reference to competition
- Analyze and evaluate regulatory and reimbursement strategy and submissions, subcontractors agreements
- Anticipate the impact of changes in the regulatory and market access environments on product portfolios
- Verify manufacturing operations, resources and quality systems to ensure adequacy with applicable regulatory requirements (GMP, GCP, GLP, 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 products for the 9 years to come, and/or that can only be approved for a small subset of the target patient population
- Which will require 3 times more patients in phase 3 pivotal trials as compared with plans
- For which consultations with regulatory authorities 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
- Is manufactured by a supplier, whose authorizations have been withdrawn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