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 a global presence and was seeking a trusted partner to initiate license transfer in all the countries where the drug was approved and to act as legal representative for the company. Client did not have any experience with Brazil regulations related to biologics and requirements as per ongoing safety compliance for complex molecules.
GRP Brazil has decades of experience in obtaining successful approval for new drugs, transfer of existing marketing authorization licenses and maintenance of products’ lifecycle in the country in compliance with local regulatory requirements. GRP Brazil provided the following services:
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