India

INDIA

Amarant Lifesciences, a regulatory consultant, provides clear strategies for timely product filings and registrations. With our in-depth knowledge of the Indian regulatory landscape, we can help you navigate the intricacies and achieve your goals smoothly. Trust Amarant for end-to-end assistance with CDSCO, MOH, AYUSH, and associated regulatory bodies.

Services We Offer

  • Strategic regulatory consultation
  • FDA registration for import of Drugs / APIs in India
  • Site registration with CDSCO India
  • Cosmetic Registration for import in India
  • New product license for manufacturing in India
  • FSSAI registration (Food & Ingredients registration in India)
  • BE Studies NOC
  • IVD & Medical device registration
  • Regulatory affairs & regulatory intelligence
  • Test License for Importing finished Formulation and APIs
  • Dossier (preparation, evaluation, and compliance)
  • Registration pathways and license management services
  • Authorised agent services
  • Import licences
  • Marketing authorization applications, renewals, transfers & life cycle management
  • End-to-end registrations
  • GMP, GLP, GCP, GDP, GVP audits (GxP)
  • Periodic safety update reports (PSURs), Addendum to clinical overviews (AtCOs)
  • Medical Writing: investigator brochures, clinical trial protocols and clinical study reports, CTD modules, safety narratives, CSR writing, protocols
  • Review of advertisements, promotional materials & Product claims assistance based on Scientific literature/ Clinical trial studies/ Nutritional studies