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.


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


Viyona Pharmaceuticals

Registered Office - Viyona Pharmaceuticals India Pvt Ltd 6-96, Plot No 217 Prashanth Nagar, Opp Bandlaguda Hyderabad - 500086

☎ Phone - +91 9650089729

© 2019 Viyona Pharmaceuticals India Private Limited.