MICHMER provides regulatory services to sponsors and institutions in several regulatory areas:
Regulatory consultation on FDA, GCP, HIPPA compliance
Informed Consent design, protocol writing
Preparation and Filing of Investigators initiated IND/IDEs
Safety reporting to regulatory bodies
Clinical study reports
MICHMER also prepares, submits, tracks, and maintains clinical trial applications to the regulatory authorities and reviews the clinical trial documentation to ensure compliance with all applicable GCP and regulatory guidelines.
Our regulatory affairs specialists work closely with the monitors to ensure that safety information is appropriately collected, evaluated, and reported, including serious adverse events and other significant safety events.
Our staff offers the best solutions to meet all kinds of challenges for pharmaceutical, biotechnology, diagnostics and CRO industries.