Regulatory Services

Regulatory Services

As experts with more than 1,000 regulatory submissions under our belt, VITACURA has the capabilities to support the regulatory end-to-end lifecycle management across the entire value chain of drug and device regulatory environment. We offer unit-based pricing, which is our unique outcome-based engagement structure where clients pay in line with the submission workload. Our lean, reliable, and cost-effective partnership model is designed to ensure a smooth approval process while optimizing costs, accelerating time-to-market, and reducing risk of non-compliance/de-licensing.

Our Regulatory offerings includes:

  • Regulatory Consulting
  • Global submission management and follow up.
  • License maintenance for marketed products
  • Application management services
  • Dossier Preparation services
  • Facilitating BA & BE studies

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