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 with a ‘right Regulatory approach’. As part of product, market and Regulatory pathway strategy services, Freyr provides comprehensive support related to:

  • 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)
  • 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 legislations realted 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