Our knowledge and experience of the pharmaceutical industry enable us advising our clients on medical devices life cycle and industry.
We provide specialized advice to several regulatory matters related to the human medicines and to medical devices life cycle and in issues that are subject to pharmaceutical and health rules and regulations, particularly regulatory, competition, industrial property, marketing authorizations, notices to the Regulatory Authorities, wholesale distribution and clinical trials on medicinal products for human use and pharmaceutical laws.
Whenever required, we work with the regulatory authorities, namely, INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde - National Authority for Medicines and Health Products, Instituto Nacional da Propriedade Industrial - National Institute for Industrial Property, and Comissão Nacional de Proteção de Dados - Portuguese Data Protection Authority, as well as with associations of this sector, namely, APIFARMA (regarding pharmaceutical industry).
CTSU provides legal assistance in pharmaceutical area covering, namely, the following matters:
- Regulatory procedures and issues;
- Preparation and revision of documentation under the required procedures regarding, namely, production license agreements, prices revision, prices reimbursements and reimbursement agreements;
- Contacts with the National Authority for Medicines and Health Products, namely, in the context of license agreements reimbursements, prices and advertising of human medicines and medical devices;
- Public procurement;
- Protection of pharmaceutical patents.