Overview

Aiming at diversification of medicinal products and medical devices manufacturing base, Sri Lanka offers good business opportunities for Pharma, Biogen and Generic product manufacturers. For the market entry, however, the new entrants are obliged to obtain approvals from Cosmetics, Devices, & Drug Regulatory Authority (CDDA). Only drugs/devices registered and compliant with the authority standards can be manufactured, imported and marketed for sale in the region. Lack of updated Regulatory knowledge may sometime challenge or restrict manufacturers’ compliance efforts. 

With an expert Regulatory affairs consulting team, Freyr assists manufacturers to decode the complex Regulatory requirements in the region and help them navigate the procedural challenges in time for successful market authorizations. Freyr’s Regulatory services in Sri Lanka span across:

  • Medical Devices
  • Pharmaceuticals
  • Cosmetics
  • Food and Dietary Supplements
  • OTC
  • Veterinary

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Marketing authorizations maintenance: Variations, renewals, notifications
  • Regulatory Submissions & Publishing
  • Regulatory Labeling & Artwork

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – With State Medical Corporation, MoH, Narcotic Products (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