REGULATORY COMPLIANCE

Our senior consultants are certified toxicologists with substantial toxicological regulatory experience in the application of relevant legislation. We closely follow scientific and regulatory developments in our field and highlight our insights on a number of topics within our domain.

The toxicology regulatory experts of ToxHub stay always abreast of the regulatory developments applicable to the industry sectors we support.

Our experience and in-depth knowledge is the basis of our regulatory compliance services. With our in-depth understanding of the data and documentation requirements as well as our knowledge how to perform the state-of-the-art risk assessments, we guide our clients through all necessary steps to achieve compliance with the regulations for pharmaceuticals, medical devices, consumer and cosmetic products.

Our regulatory services for all our industry clients include:

  • Implementation of regulatory strategy including (but not limited to): preparation of Scientific Advice and Protocol Assistance, pre-IND and End of Phase II packages (focus on non-clinics);
  • Support and facilitation of specific regulatory interactions with authorities in support of first-in-human studies – including compilation of supporting documentation, IB, IMPDs, INDs, etc;
  • Addressing specific toxicology issues raised by regulatory agencies;
  • Preparation of responses to authority requests (Deficiency Letters – DL) and/or advocating and defending scientific approaches with public authorities (e.g., ECHA, EMA, EFSA, and national authorities);
  • Data compilation, evaluation of non-testing approaches and waiving opportunities, final data gap analysis;
  • Design and management of testing programs;
  • Development of Regulation-compliant registration dossiers or submissions including compilation of supporting documentation, IB, IMPDs, INDs, etc;
  • Product information files (PIF) in agreement with Cosmetics Regulation;
  • Cosmetic ingredient dossiers for SCCS submission;
  • Biological evaluation of medical Devices in agreement with EU MD Regulation.