Regulatory Strategy

Getting your product to market requires navigating the regulatory review process. Our ToxSmart subject matter experts can help you successfully navigate the complex regulatory approval landscape.

Understanding Regulatory Review 

Program success is determined by satisfying the regulatory review who have demands that are shaped by key opinion leaders (KOLs). ToxSmart stays current with trends in regulatory guidance through frequent communication with these thought leaders; this often leads to positive, science-driven interactions with regulatory agencies. Our subject matter experts can help you navigate this complex regulatory approval landscape.

Early involvement with regulatory agencies for study design can lead to a greater chance for successful approval. A pre-IND meeting is now a requirement to getting your product to market for many of the new and innovative therapies being developed today. Our consultants help you prepare for meetings with the FDA, provide you with analyses to support regulatory submissions, and deliver justification to support your approach.

Regulatory Guidance

  • ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process
  • ISO 10993-17: Biological Evaluation of Medical Devices – Part 17: Establishment of Allowable Limits for Leachable Substances
  • ICH Q3D. 2015: Elemental Impurities: Guidance for Industry, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER)
  • ICH M7. 2015: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, Guidance for Industry
  • ISO 14971, 2007: International Standard. Medical Devices- Application of Risk Management to Medical Devices. Second Edition. Reference Number ISO 14791:2007(E).
  • ISO 18562: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications