In our Regulatory compliance practice area we specialize in regulatory compliance for the health sector and other regulated industries. This is important because non-compliance with these regulations can result in penalties and fines for companies, as well as risks to public health and consumer rights.
Previously, we have worked supporting companies in the process of importing or marketing in Colombia of medicines to treat specific diseases. In the same line, we have extensive experience in obtaining multiple health registrations from INVIMA (Instituto Nacional de Vigilancia de Medicamentos, Alimentos y Productos Médicos), which is the Colombian National Institute for Food, Medicine, and Medical Device Surveillance. It is the government agency responsible for regulating and controlling the safety, quality, and efficacy of food, drugs, medical devices, and cosmetics in Colombia.
In addition, as a complement to the protection of business innovation, our team has extensive experience advising pharmaceutical companies of innovative and generic products in matters relating to test data protection and the creation of plant varieties with application in various sectors and, particularly, in disruptive industries such as medical cannabis.
We have expertise in drug pricing and advertising regulations. We have successfully defended companies in regulatory investigations
We are a leading regulatory compliance law firm for the pharmaceutical, cosmetic, and agrochemical industries. We have an interdisciplinary team highly trained in the management and obtaining of notifications and sanitary registrations, as well as in the protection of test data and the creation of plant varieties with application in various industries.
In addition, our firm has been successful in defending companies in cases related to the sanctioning regime of medicine price control and advertising of over-the-counter and prescription medicines. We have developed effective strategies to face important and very well-known administrative authorities in Colombia.
Our experience and expertise in the healthcare industry and in sanitary regulation allow us to offer a comprehensive advisory and management service for companies in different sectors that must comply with specific requirements and regulations. In short, we are the best option for companies seeking to comply with legal requirements and gain a competitive advantage in the industry.
This service is focused on companies that wish to market products in Colombia, such as food, medicines, medical devices and chemicals, and therefore must obtain prior government approvals. Our professionals help companies navigate the regulatory processes and obtain the necessary registrations and authorizations to market their products.
Due to the multiple regulations applicable in each sector, which can be especially complex in highly regulated sectors such as healthcare and pharmaceuticals, at Nieto & Nieto Lawyers we help companies comply with applicable regulations, design compliance policies and procedures and mitigate legal risks.
Companies operating in regulated sectors often face legal and regulatory challenges, including governmental investigations, civil lawsuits and administrative sanctions, that is why at Nieto & Nieto Lawyers we offer representation to companies in litigation and disputes, to help them resolve conflicts and defend their interests in an efficient and expeditious manner.
Companies may face regulatory investigations and audits, which can be both costly and disruptive. At Nieto & Nieto Lawyers, we help clients prepare for these situations, represent them throughout the process, and implement corrective measures to prevent future issues and penalties.
Hand in hand with our Tax, Customs and Foreign Trade practice area, at Nieto & Nieto Lawyers we offer advisory services to help companies that import and export products to duly comply with international trade regulations and customs laws and avoid penalties for non-compliance.
at 93rd Street No. 11 A 28, Capital Park 93 Building, Office 701, Bogotá – Colombia.
Confidentiality Agreements
Mandates and Powers of Attorney Client – Attorney
Personal Data Processing Policies
Privacy Policy
Nieto & Nieto Lawyers / All rights reserved© 2024.