Freyr is a leading provider of specialized Regulatory Services & Solutions for the Consumer Healthcare industry supporting Forbes* Global Top 10 Fortune 100 Healthcare companies as their strategic Regulatory Partner  for end-to-end services across the entire Regulatory value chain.

 

Freyr’s Consumer Healthcare Regulatory CoE offers Regulatory Affairs and Regulatory Operations Supported services to Top 100 Brands in the world, across diverse product categories and therapeutic areas such as:

  • Upper Respiratory & Allergy | Smoking Cessation | Pain
  • Digestive Health | Topical Health | Intimate Health
  • Skin Care | Infant Care

Freyr is leading the way in helping Consumer Healthcare companies reduce their total cost of compliance by providing innovative Regulatory Supporting Solutions which includes first-of-its kind supporting of complex Regulatory functions and being able to offer cost-reductions of 40% and upwards.

Centralized Regulatory Supporting Services

  • Cosmetic Safety Assessments
  • Regulatory Submissions (eCTD, NeeS, Paper)
  • Product Core Data Sheet Management
  • Regulatory Labeling & Artwork services
  • Regulatory Process Consulting & Optimization
  • Regulatory Information Management
  • Regulatory Intelligence & Tracking for Guidelines and Restrictions associated with Raw materials / constituent information and its potential impact on Consumer products
  • Health Authority Directives
  • Evaluate Regulatory impact to consumer products for safety (i.e., CIR, SCCS, etc.), constituent regulated limits, (i.e., OTC monograph, EU Cosmetic Directives, China regulatory reform), etc.
  • Regulatory Affairs services for New Product Roll outs and Life cycle Maintenance (Dossier preparation M1 to M5, CMC, Health Authority queries, Submission pathway, Registration and License Management)

Consumer Healthcare Regulatory Dynamics - Whitepaper 

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Enabling Critical Regulatory Market Positioning and Product Launch Strategies

Freyr’s indigenously developed Reg Insight Application helps client to plan for multi-country filings, stay ahead of legislations and guidelines, and compare existing & emerging products. Download

CLIENT TESTIMONIALS

 
  • Overall the project has gone very well; with targeted submission numbers being achieved substantially ahead of the original plan.

    Associate Director, Fortune 100, Global Top 5 Consumer Healthcare Company

  • Freyr provided critical services to support the CTA approval of one of our Top 3 global oral care brand. The project management and team support was amazing. The quality, quick turnaround time, online submission and validation was remarkable. We successfully got the MHRA approval on the CTA. I want to thank the entire Freyr Team for their role in this.

    – Regulatory Affairs Franchise Manager,
    Global Top 5 Consumer Healthcare Company