Case Study 59: Marketing Authorization License Transfer in Brazil for Biologic New Drug

Company Situation

The Client is a UK based specialty pharmaceutical company that had acquired global license for a novel biologic drug, an interleukin 6 antagonist for treatment of multicentric Castleman’s disease from a large pharma company. Client did not have global presence and was seeking a trusted partner to initiate license transfer in all the countries where the drug was approved and act as legal representative for the drug. Client did not have any experience with Brazil regulations related to biologics and requirements as per ongoing safety compliance for complex molecules.

GRP Solution

GRP Brazil has decades of experience in obtaining successful approval for new drugs, transfer existing marketing authorization license and maintenance of products’ lifecycle in the country by complying with safety and quality regulations.

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