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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.

Gaining regulators’ marketing approval is – together with launch – one of the two major value points in a drug’s life cycle. Marketing Authorization Applications (MAA), New Drug Applications (NDA) or Biologic License Applications (BLA) detail how the product is manufactured and controlled, and summarize years of testing. Read More

VCLS Solutions

De-risk registration

  • Organize expert panels with medical/clinical, regulatory and health economics experts
  • Enhance communication and smoothen liaison between Sponsor and regulators before and during review processes
  • Design customized risk management mechanisms, to optimize commercialization
Manage registration procedures

  • Finalize BLAs, NDAs, MAAs (authoring or review)
  • Detail roadmaps for submitting applications in various countries of interest, and managing review processes
  • Manage communication with regulators on behalf of Sponsor throughout review procedures
Comply with post-marketing vigilances requirements

  • Identify EU Qualified Person for PharmacoVigilance for MAA
  • Adapt post-approval safety surveillance to regional/national requirements, including safety data exchange agreements (SDEAs) set-up, – literature surveillance and medical information
  • Monitor safety profile, organize global safety review boards
Implement market access strategy, develop value proposition for payers

  • Finalize value claims and data
  • Develop launch strategy, set optimal global pricing strategy





































In Europe, CE marking procedures evaluate both the product technical file and the manufacturer’s Quality Management System (QMS) to ensure compliance with applicable regulations. Similarly yet differently, Pre-Market Notification (510k) and Pre-Market Approval (PMA) are required to enter the US market. Read More

VCLS Solutions

Manage registration procedures

  • Finalize regulatory registration dossiers
  • Detail roadmaps for submitting applications internationally
Comply with vigilance and post-marketing surveillance requirements

  • Finalize vigilance system and transition to post-marketing requirements
  • Set up post-marketing surveillance plan
Implement market access strategy, develop value proposition for payers

  • Finalize value claims and data
  • Develop launch strategy, set optimal global pricing strategy