Rapid urbanization, increased consumer spending and projected growth rates signifies a better scope for foreign medicine or medical device manufacturers who are willing to enter the Indian subcontinent. India’s regulatory regime for pharmaceuticals and medical devices is regulated by the Central Drug Standards Control Organization (CDSCO). 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.

Freyr, as a specialist global Regulatory partner exclusively focusing on the entire Regulatory value-chain of Bio-Pharma (Innovators / Generics), Consumer Healthcare and Medical Device companies, provides best-in-class Regulatory Affairs and consultancy services to assist foreign manufacturers navigate through the complex Regulatory procedures in the region. As a full-service global Regulatory Solutions and Services Company Freyr’s Regulatory services in India span across:

Freyr Offerings

  • 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
  • CSR Writing, Protocol Writing
  • Review of advertisements, promotional materials 

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with CDSCO, MOH.
  • Expert Regulatory team with proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines