Handling applications including mandatory and comprehensive documentation for pharmaceutical drugs and/or medical devices is not only a day-to-day business for the consultants of IASON consulting, but also our passion.
A key instrument to our success is our extensive experience within the process of drug and/or device application and approval processes. Our professional and independent team of IASON consultants has provided high-quality strategic and operational input into drug and device development since 2004. Every project is accounted for by more than 15 years of experience and by our interdisciplinary team of toxicologists, pathologists, biologists, and veterinary surgeons.
Investigator Brochures aim to maintain human safety throughout clinical trials and aim to provide necessary information for an unbiased risk-benefit assessment.
IBs by IASON consulting are written according to the most current regulatory requirements and guidelines of the U.S. Food and Drug Administration (FDA) and the International Conference of Harmonisation (ICH).
Document preparation and reoccurring reviews for submission in the European Union, Japan, and the United States are provided with the uttermost attention to current developments within the health care sector.
Contact us now to find out more about our Investigator’s Brochure service.