Phone :+1-306-992-2818 | +91 80088-22584

Email :info@viyonapharmaceuticals.com

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

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