Case Study 51: Registration of DMF Type II with FDA

Company Situation

Client was looking for a local agent to support the registration of a type II DMF with the FDA for the serum CellCor. The product does not have any derived components of animal and plant and it is used to increase life expectancy in humans as well as living healthy.

GRP Solution

GRP stepped up as a Strategic Regulatory Partner for the client from South Korea to support its business expansion in USA.

In USA, Type II DMF is related to DMF for drug substance, drug substance intermediate, and materials used in their preparation, or drug product.

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