LLOREDA CAMACHO & CO is the industry leader in the provision of legal services related to regulatory matters that come before the health authority (INVIMA) and has been recognized by international publications, such as Chambers and Partners, as the highest-ranking law firm in Colombia in this field.
Within this practice, we counsel the main R&D companies in sectors such as pharmaceutical, biotechnology, medical devices, food, drinks and cosmetics in Colombia.
We advise our clients on a wide range of regulatory issues at each stage of the life cycle of their products, including:
- Structuring strategies for marketing authorization (preparation and processing of applications for health records, renewals, modifications, certifications and authorizations that are required in advance by INVIMA).
- Promotional practices.
- Post-marketing Pharmacovigilance plans.
One of the main focuses of our department is to provide specialized legal advice on issues such as data protection, registration procedures, development of clinical studies, marketing activities, advertising and labeling.
We have been recognized in regulating the pricing of pharmaceuticals which has proven to be a very active field of practical experience in this specific area.
Our firm has actively participated in the drafting of regulations issued by official organizations related to marketing approval for biotechnological products and biosimilars in Colombia Decree 1782 of 2014. We are also actively involved in the drafting of guidelines related to topics of immunogenicity and pharmacovigilance currently being developed by the government.
Also, we have considerable experience in advising various pharmaceutical companies in the process of obtaining marketing authorization of biotechnology and pharmaceuticals.
We also have extensive experience in reviewing the business practices of our customers in the light of Colombian law transparency and anticorruption, making recommendations when and where needed, with regard to best practices and full regulatory compliance.
Our attorneys’ regulatory group works closely with our patents team to provide an integrated approach of the major legal issues of our clients involved in the marketing of their products.
Our team is made up of two partners, two former officials of INVIMA associates, three technical advisers and three assistants.