As a key function of Freyr’s Regulatory & Business Consulting offerings, we offer Large & Small-Medium Life Sciences companies the benefits of cost-effective, consulting services to help them with the ‘right Regulatory approach’.

 

Various parameters are evaluated to provide the right Regulatory strategy. A few of them are outlined below.

  • Past history and pattern of Regulatory approvals, re-calls and rejections for respective products, to the Health Authority (HA) / Market to which approval is being solicited
  • The appropriate Regulatory pathway when regional complexities are present (e.g.: EU – National Procedure, De Centralized Procedure-DCP, Mutually Recognized Procedure-MRP )
  • Appropriate Submission format approach
  • Ongoing tracking of Ingredient-level / Safety & Scientific information services to help in better product / formulations strategy from a Regulatory perspective
  • Monitor changing legislation as it relates to Toxicology, Regulatory, Environmental, etc.
  • Evaluate Regulatory impact to products for 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