Regulatory Consulting

Though the Indian pharmaceutical market seems to be lucrative, the region’s increasing regulations might pose challenges for foreign manufacturers to approach the product registrations and health authority approvals for streamlined market authorizations.

As a full-service global Regulatory Solutions and Services Provider Wayinia Regulatory services in India span across:

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services,
  • Marketing authorization applications, renewals
  • End-to-end registrations
  • Dossier (preparation, evaluation and compliance)
  • Market Authorization Transfer and Life Cycle Management
  • GMP/GLP, GCP and audit of GxP IT systems
  • Pharmacovigilance
  • Periodic Safety Update Report (PSUR)
  • Medical Writing: Investigator Brochure, clinical trial protocols and Clinical Study Reports, PSURs, Addendum to Clinical Overview (ADCO), CTD modules, safety narratives
  • CSR Writing, Protocol Writing
  • Review of advertisements, promotional materials
  • Product claims assistance based on Scientific literature/ Clinical trial studies/ Nutritional studies