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Pharmaceutical Law – Data Protection - Life Sciences

The protection of pharmaceutical products is one of the few areas where experts agree that legal protection is essential to foster innovation. Indeed, the launch of a pharmaceutical product in the market is a long and difficult process that implies the investment of enormous resources and the generation of a significant amount of necessary information to obtain the regulatory authorization to allow its commercialization, which constitutes one of the most valuable assets of a pharmaceutical company.

Also, and increasingly, the IP aspects of pharmaceutical and agro-chemical products are related to the registration process before the specialized regulatory authorities, considering the need to protect the data that the applicant must provide to obtain the authorization to sell their products. Our attorneys have experience in negotiations and regulatory litigations, and also in the management of the provisions for data protection, and are thus in a unique position to advise our clients regarding these matters.

Additionally, the provisions of bioequivalence and biosimilars are becoming increasingly relevant in the process of registration and sale authorizations of pharmaceutical products, because their infringement can lead to the rejection or cancellation of said registration. The attorneys and technicians of our firm can provide the necessary guidance and advice in regulatory matters.

At the same time, our team constantly monitors legal and regulatory changes that may affect the industry and the pharmaceutical market, allowing us to provide updated advice to the industry in a field that is constantly being updated.

Finally, our firm has experience in legal issues related to the importation, commercialization and pharmacovigilance of pharmaceutical products and the rules for their acquisition and distribution by public and private entities (including public tenders), as well as in advertising, medical promotions, and telemedicine, among other matters.