go global

SERVICES

Regulatory

It is important to understand and define the clear regulatory strategy by considering the target markets/ regions, different patent terms and its extension, various application possibilities, data requirements, deadlines for launching products to be marketed in different markets/ regions.

We support in

Regulatory Filing – Regulatory Filing Strategy, Document Preparation and Reviews Regulatory Compliance Issues – Response Strategy and Response Drafting / Preparation / Review, Issue Resolution Plan.

Regulatory

OUR REGULATORY SERVICES INCLUDE:

  • Advising eligibility of products and level of registration required
  • Indian regulatory compliance
  • Evidence packages
  • Export certification
  • Label compliance
  • Maintenance of marketing licenses, permits and other compliance related activities through the life of a product
  • Preparation and submission of listing applications to all regulatory agencies
  • Preparation of product Registration Dossier packages
  • Regulatory compliance with international health authorities in all markets