Hamza Law Firm assists you on both regulatory and litigation levels in the disciplines of life sciences, health and pharmaceuticals.
we provides multidisciplinary services that cover the health sector industry, pharmaceutical companies, dietary supplements, biotechnology, biocides, plant protection products and cosmetics. In this respect, we assist pharmaceutical companies that produce originators or generics, medical device manufacturers, distributors as well as professionals and health organizations.
The products of these companies go through several stages and are subject to rather complex regulations requiring a great deal of expertise. Hamza Law Firm is highly qualified to support companies in the health and pharmaceutical sector in the legal monitoring of their product and provides the necessary assistance from the manufacturing stage, evaluation, marketing to distribution.
Our expertise covers industrial property, corporate law, mergers & acquisitions and competition law.
We advise you and assist you in your activities in relation to the administrative bodies and the ordinal authorities. We ensure your defense in case of legal or ordinal litigation, concerning the sector of life sciences, health and pharmaceuticals.
Registration and Marketing Authorization Procedures
Hamza law Firm assists you in the procedures of registration of your medicines and in obtaining the authorization of placing on the market (AMM) in Tunisia. The AMM application is filed and renewed with the Pharmacy and Drug Directorate (DPM).
You are also assisted in the procedures for obtaining the clearance for home use (CMA).
- Hamza law Firm, is highly specialized in industrial property, including life sciences law. We intervene for the protection of your patents and undisclosed data submitted for the approval of pharmaceutical products.
- We draft all types of contracts: research contract, partnership contract, development contract, confidentiality agreement, coexistence agreement, license agreement, assignment contract. We also handle trademark and patent litigation beforethe competent courts.
Pharmaceutical companies law
Hamza Law Firm assists pharmaceutical companies in their installation and development procedures on the Tunisian market.
We assist laboratories, health and biotechnology companies in the legal framework and financial structuring for the exercise and growth of their activity, as well as the drafting of commercial contracts for the distribution of pharmaceutical products.
Risks and responsibilities
We assist pharmaceutical companies in disputes related to the responsibility for research and clinical trials or industrial risk liability for marketed pharmaceuticals.