With a right Regulatory approach as a key function of business consulting, Freyr offers Large & Small-Medium Life Sciences companies cost-effective product, market and Regulatory pathway strategies, which includes:
- Drug Registration Pathway
- Market Strategy Report
- Marketing Authorization Renewal
Various parameters are evaluated to provide the right market strategy report. A few of them include:
- History and pattern of Regulatory approvals, marketing authorization renewals, re-calls and rejections for respective products, to the Health Authority (HA)/Market to which approval is being solicited
- Appropriate drug registration and Regulatory pathway when regional complexities are present (e.g. EU – National Procedure, De Centralized Procedure-DCP, Mutually Recognized Procedure-MRP)
- Regulatory approach with appropriate submission formats
- Continuous tracking of ingredient-level/safety & scientific information services to help in better product/formulations strategy from a Regulatory perspective
- Monitor changing legislation related to toxicology, Regulatory, environmental, etc.
- Evaluate Regulatory impact of products' safety (i.e., Cosmetic Ingredient Review – CIR, EU Scientific Committee on Consumer Safety – SCCS, etc.), constituent regulated limits, (i.e., OTC monograph, EU Cosmetic Directives, China Regulatory reform), etc.
- Verification of trade name, manufacturer, INCI(s), CAS/EINECS, and percentage or constituent
- Evaluate potential impact on new guideline or restriction and/or reporting/documentation requirements