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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.

Successful launch is the second major value point in a drug’s life cycle. While market approval is grounded on quality, safety and efficacy, market access is contingent upon additionally demonstrating cost-effectiveness to payers. Reimbursement authorities assess the impact of the use of a new drug on healthcare budgets, and determine a price, a level of reimbursement, potential limitations in prescribing, as well as consequences of exceeding sales volumes or average daily dose. Read More

VCLS Solutions

Pre-Launch Activities

  • Define targeted medical communication to ensure maximum visibility and knowledge for medical professionals, and hence ensure wider and better use
  • Optimize price and reimbursement
    • Adapt core value dossier to local requirements and negotiate with payers
    • Assess line extension opportunities
    • Adapt market access strategy upon competitor launch and patent expiry
  • Optimize product value through partnering
    • Provide strategic advice on partnering opportunities
    • Ensure Quality Improvement / Cost reduction to face competition from generics/biosimilars

Life Cycle Management

  • Manage variations and post-approval commitments:
    • Define and implement strategy for managing variations and post-approval commitments
    • Grouping and worksharing variations procedures
    • Regulatory intelligence: watch and assess impact of regulatory changes
  • Develop product value
    • Assess opportunities in new indications, product repositioning
    • Monitor competition
  • Ensure crisis management
  • Manage unexpected regulatory or safety issues
  • Support affiliates to develop Quality Management System








































Post marketing surveillance (PMS) is organized to monitor the safety and performance of the product once used by large number of patients in the targeted population, and to ensure a sustainable risk/benefit balance.

Agreements are established with distributors in particular to define the split of regulatory responsibilities between the different stakeholders (Manufacturer/distributor). Promotional materials are developed for each market, in compliance with local regulatory requirements. Read More

VCLS Solutions

Pre-Launch Activities

  • Adapt core value dossier to local requirements and negotiate with payers
  • Adapt market access strategy upon competitor launch

Life Cycle Management

  • Manage post-market surveillance
  • Assess opportunities in new indications, product repositioning, need of additional clinical studies in new indications
  • Manage unexpected regulatory or safety issues