Regulatory Law

We have a highly qualified multidisciplinary team experienced in the preparation, presentation and monitoring of health registration applications, for products such as pharmaceutical, biological and biotechnological products, New Chemical Entities, phytotherapeutic, homeopathic, natural resources based products, cosmetics, hygiene and cleaning products, medical devices of any classification, biomedical equipment, diagnostic reagents, dietary supplements, food products for any risk classification, and liquors. Our clients represent a wide range of national and international industries, such as pharmaceuticals, cosmetics, food, among others.

Our service is aimed at providing our clients added value, which is why our review and preparation of the application files are supported technically and legally in order to expedite the applications before the INVIMA.

We provide experienced analysis over health registration violations which may lead to an administrative investigation and sanctioning process by the INVIMA, so as to defend our clients interest and rights.

We handle international health registration portfolios.

We have a highly qualified multidisciplinary team experienced in preparation, presentation and monitoring of health registration applications for the production, import, export, commercialization and use of agricultural products and of agricultural origin, such as fertilizers, soil conditioners, agricultural biosupplies, among others, as well as veterinary products such as food, medicines, and livestock supplies in general, both in Colombia and other countries.

Our service is aimed at providing our clients added value, which is why our review and preparation of the application files are supported technically and legally in order to expedite the applications before the ICA.

We provide experienced analysis over health registration violations which may lead to an administrative investigation and sanctioning process by the ICA, so as to defend our clients interest and rights.

We handle international health registration portfolios.

We advise our clients in the preparation, presentation and monitoring of applications of New Chemical Entities under the protection of Decree 2085.

Our service is aimed at providing our clients added value, which is why our review and preparation of the application files are supported technically and legally in order to assure the greatest protection as set forth under Decree 2085.

Litigation before the administrative authorities for the protection of undisclosed data under Decree 2085.

We advise our clients in the review, filing and approval of advertising and promotional material for all types of products and in all industries. Litigation before administrative and judicial authorities.

We advise our clients which produce locally in the preparation, filing and issuance of certificate of Good Manufacturing Practices, Certificate of Manufacture, as well as extension, modification and renewal of the same.

Specialized consultancy in the preparation, filing and monitoring of applications.
Granting and extension of quotas.

We advise laboratories in the preparation, filing and approval of clinical protocols.

We offer training related to all aspects of regulatory law, adapting the trainings according to the audience and the purpose of the training.

Our training covers topics ranging from the general, so as to introduce one to more regulatory law topics, to the highly specialized, in order to discuss new or controversial issues.

We advise our clients in all contractual aspects related to Regulatory Law. This includes licensing contracts, maquila, manufacturing, distribution, sale and purchase of health registrations and know-how.

Our firm has extensive experience in the management of health registration portfolios, including those for products for human consumption as well as agricultural and livestock products.

For these purposes, we have a mature network of agents in most countries around the world, which allows our clients to centralize the management of their regulatory rights in raisbeck & castro, facilitating their administrative processes and maintaining an optimum level of quality.

When regulatory rights are to be acquired or licensed, as well as when investments are to be made in companies whose health registrations are a determinant aspect of the investment, it is important to establish the status and validity of such rights as part of the process of determining the legal basis and value of the purchase, license or investment contract. This is where our firm advises our clients in the full evaluation of the rights in question, conducting a due diligence not only to establish the current status and validity of each right, but to establish possible legal contingencies that provide our clients with the elements necessary to make educated decisions.

We advise and represent our clients before the Colombian Government and Congress, as well as the Andean Community, to promote our clients' interests in legislative development related to all aspects of regulatory law.