Solutions for Each Stage of Development
From preclinical through to commercialization.
Our team’s integrated specialist skills enable to address current challenges, while
preparing for next steps along the product timeline.

The regulatory and reimbursement environments are two of the most important external factors affecting a company's development strategy. VCLS guides Pharmaceutical and Biotech innovators throughout the drugs’ life cycle, from preclinical development through commercialization, in all regulated areas: Quality, Safety, Efficacy, and Cost-Effectiveness.

Product development strategy

  • Global development strategy
  • Regulatory strategy
  • CMC, nonclinical and clinical development plans
  • Launch, pricing and reimbursement strategies
  • Life cycle management and line extension(s)
  • Due diligence / opportunity assessment
Communication with health authorities

  • Obtain regulator and payer feedback on development plans and approval strategies
  • Develop value proposition for payers
  • Prepare and submit regulatory, pricing and reimbursement applications
  • Link manufacturing attributes with regulatory requirements
  • Monitor safety profile
  • Ensure quality compliance
  • Bridge regulators’ and payers’ requirements

VCLS guides Medtech innovators throughout medical devices life cycle, from strategy through execution, in all regulated areas: Quality, Safety, Performance, and Cost-Effectiveness.

Science-based, global product development strategy and planning

  • Product qualification and classification
  • Claims positioning
  • Regulatory bodies strategic and product development meetings (Notified Bodies, EU Competent Authorities, FDA)
  • Roadmaps towards international regulatory approval
  • Risk management
  • Nonclinical and clinical development plan
  • Launch, pricing and reimbursement strategies
  • Due diligence / business opportunity assessment
Tactical operations

  • Risk analysis
  • Preclinical and clinical literature reviews
  • Clinical study design, development and submission of essential documentation
  • Clinical Trial submissions to international regulatory authorities (EU Competent Authorities/Ethics Committees, FDA/Institutional Review Boards)
  • Clinical evaluation report
  • Quality System Management
  • On-site assistance for regulatory audits
  • Product registration/notification in international markets (EU incl. CE mark Technical File, US incl. 510k & PMA, Canada, Australasia, South America)
  • Vigilance systems and safety cases management
  • Post-marketing surveillance (PMS)
  • Develop value proposition for payer
  • Labeling, Advertising & Promotion
  • Distribution requirements and contract review
  • European authorized representative and US agent