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 Outsourced 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 Outsourcing Solutions which includes first-of-its kind outsourcing of complex Regulatory functions and being able to offer cost-reductions of 40% and upwards.
Centralized Regulatory Outsourcing 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)