FDA De Novo Classification Request for Medical Devices
GRP’s presentation provides insights on requirements and processes for requesting a De Novo classification request to the FDA.
Establishments Registration and Drugs Listing with FDA
GRP’s presentation provides an overview on the Establishment Registration with the FDA including who is required and not required to register.
OTC MONOGRAPH REFORM IN THE CARES ACT: FDA INITIATED SAFETY ORDERS
GRP’s presentation outlines important information FDA OTC Monograph Reform.
Overview of FDA De Novo Program
GRP’s presentation outlines important information on FDA Denovo Program for Medical Devices.
FDA Requirements for Investigation New Drug (IND) in USA
GRP’s presentation outlines important information IND requirements with the US FDA.
Overview of the Registration Process of DMF Type II (API) with US FDA
GRP’s presentation provides an overview of the registration process for Drug Master File type II used for API registration with the US FDA.
GRP brochure: USA services
We are a global consulting and market access firm headquatered in boston, massachusetts that provides regulatory affairs, quality, clinical andsafety services to pharma, biotech, lifestyle consumer companies worldwide for their product registration and compliance with the US FDA.