Regulatory and Sanitary

In our Regulatory and Sanitary practice area, we focus on advising companies and individuals on compliance with the regulations governing the health sector and other regulated sectors such as cosmetics and personal care, food, agrochemicals, and pharmaceuticals. This is important because non-compliance with these regulations may result in sanctions and fines for companies, as well as risks to public health and consumer rights.

Our practice area in regulatory and sanitary

At Nieto Lawyers, the Regulatory and Sanitary Practice Area is designed to ensure that products such as medicines, food, medical devices, and cosmetics comply with all current health regulations in Colombia. This specialized service enables companies to obtain and maintain their sanitary registrations with INVIMA, guaranteeing compliance with the quality, safety, and efficacy standards required by Colombian law. Since the creation of INVIMA in 1995, health regulation in Colombia has evolved to protect public health and ensure the safe commercialization of products for human consumption. At Nieto Lawyers, we help our clients navigate this regulatory process, mitigating risks and avoiding sanctions. Our team of experts works hand in hand with each client to meet sanitary requirements and ensure the legal distribution of their products in the Colombian market.

The Importance of Health Regulation

Complying with health regulations is essential for any company seeking to operate in Colombia. Obtaining the proper sanitary registration ensures that products meet the required quality and safety standards to protect consumers. At Nieto Lawyers, we simplify the regulatory process by guiding our clients through every step — from registration to maintaining their products on the market.

 

Why Nieto Lawyers Is the Right Partner for Your Regulatory Compliance Needs

With a focus on regulatory compliance, risk management, and safe market access, Nieto Lawyers provides comprehensive solutions to help companies comply with INVIMA regulations. Our goal is to safeguard public health while supporting the secure and sustainable growth of our clients in Colombia.

Nuestros

Services

At Nieto Lawyers, our specialized focus on sanitary registration and regulatory services ensures that your products meet all requirements for commercialization in the Colombian market. From INVIMA sanitary registration to compliance with food and import regulations, our team of experts manages every detail—streamlining processes and preventing unnecessary delays. Trust us to take your products to the next level, in full compliance with the law, so you can focus on what truly matters: growing and thriving in a competitive market.

1. Regulatory Compliance Product Registration and Authorization

This service is designed for companies seeking to market products in Colombia—such as food, pharmaceuticals, medical devices, and chemical products—that require prior government authorization. Our professionals assist businesses in navigating regulatory processes and securing the registrations and approvals necessary to bring their products to market.

2. Regulatory Compliance

Due to the multiple regulations applicable in each sector—particularly in highly regulated industries such as healthcare and pharmaceuticals—Nieto & Nieto Lawyers assists companies in achieving compliance with applicable laws, designing effective compliance policies and procedures, and mitigating legal risks.

3. Legal Representation in Litigation and Dispute Resolution

Companies operating in regulated industries often face legal and regulatory challenges, including government investigations, civil lawsuits, and administrative sanctions. That is why at Nieto & Nieto Lawyers we provide representation in litigation and disputes, helping businesses resolve conflicts and defend their interests efficiently and effectively.

4. Representation in Investigations and Audits

Companies may be subject to regulatory investigations and audits, which can be costly and disruptive to their operations. That is why at Nieto & Nieto Lawyers, we help businesses prepare for investigations and audits, represent them throughout the process, and assist in implementing improvements to their business practices to prevent future investigations and sanctions.

5. Full-Service International Trade Consulting

Through our practice area at Nieto & Nieto Lawyers, we provide advisory services to companies engaged in importing and exporting products, ensuring full compliance with international trade regulations and customs laws, while helping to avoid penalties for non-compliance.

6. Comprehensive Intellectual Property Advisory

Protect what makes your company and products unique with the support of intellectual property specialists. At Nieto Lawyers, we have a dedicated Intellectual Property practice because we understand that your innovations, brand, and technological developments are at the heart of your business. That is why we offer comprehensive intellectual property advisory services designed to ensure your rights are protected in every market where you wish to compete.

Client Success Stories

At Nieto Lawyers, our commitment to excellence has enabled us to achieve outstanding results in every project. We have a team of experts, including pharmacists, chemists, and biomedical engineers, who have achieved a 100% success rate in lifting suspensions and renewals, and a 91% success rate in obtaining sanitary registration for critical products. Here we share some of our most notable achievements:

Ready to take the next step in regulating your products? Contact us now for a free consultation. A professional from our team will be happy to assist you and guide you in selecting the services you need. At Nieto Lawyers Regulatory and Sanitary Services, we don’t just meet your expectations—we exceed them.

Guaranteed Results

Over our 24 years of experience, Nieto Lawyers, together with our professionals in pharmaceuticals, chemistry, and biomedical engineering, has achieved outstanding results in the following areas, making a significant impact on the continuity of healthcare services and the optimization of processes for our clients.

Modifications

100%

Responses to Requests

91%

Obtaining New Sanitary Registration

95%

Resolution of Suspensions

100%

License Renewals

100%

NIeto Lawyers

Why Choose Us

Our law firm is a leader in the regulatory and sanitary practice area in Colombia, thanks to our extensive experience and deep knowledge of the laws and regulations governing the pharmaceutical, cosmetic, and agrochemical industries. We have a highly skilled interdisciplinary team specializing in the management and acquisition of sanitary notifications and registrations, as well as the protection of test data and the development of plant varieties applicable to various industries.

Additionally, our firm has a proven track record in defending companies in cases related to the sanctions regime for drug price control and the advertising of both over-the-counter and prescription medications. We have developed effective strategies for dealing with administrative authorities, including the Delegation for the Control and Verification of Technical Regulations and Legal Metrology, the Superintendence of Industry and Commerce, and INVIMA.

Our experience and expertise in the healthcare industry and sanitary regulation allow us to provide comprehensive advisory and procedural management services for companies across different sectors that must comply with specific requirements and regulations. In short, we are the best choice for companies seeking to meet legal requirements and gain a competitive edge in the industry.

– 24 Years of Experience
– Multidisciplinary Team
– Members of the Chamber of Commerce
– Procedures and filings completed in record time
– Certification of Ethical and Business Responsibility from the Chamber of Commerce

Transforming Health Regulation in a Digital and Globalized World

In a world where technology and data are transforming various industries, Nieto Lawyers stands out as the ideal partner for companies seeking to innovate in the healthcare market, comply with stringent regulations, and expand internationally. Our team combines expertise in health regulation with advanced knowledge in digital transformation, technological innovation, foreign investment, and international business.

Our Approach

Global Compliance

We ensure that your healthcare and sanitary products comply with international regulations, facilitating a safe and efficient entry into new markets.

Technology Serving Healthcare

We specialize in integrating technological solutions to enhance efficiency, data protection, and product safety in the healthcare sector.

Strategic Expansion:

We support you at every step of your international investment, from entering new markets to adapting to local regulations and establishing strategic partnerships.

NIeto Lawyers

Discover how we can take your business to the next level.

Explore our areas of expertise in Foreign Investment and International Business, Technology, Data, and Digital Transformation, and Medicines and Health Sciences, and discover how Nieto Lawyers can be the partner you need to tackle the challenges of the digital era across all regulatory matters.

Our Team

What Our Clients Say

5.0
Based on 11 reviews
powered by Google
contacto EntreObras
21:15 16 Aug 23
Como empresa colombiana, con experiencia en contratos de construcción e ingeniería, nos enfrentamos con un tema puntual de responsabilidad contractual, en el marco de un consorcio en una obra pública. Necesitábamos un abogado especializado en contratos, y fue así como recurrimos al Abog. Jaime Andrés Nieto, especialista y profesor en esta área, quien es líder del área de práctica de contratación estatal en la consultora Nieto Lawyers. Desde el primer momento, el Abog. Jaime Andrés nos brindó confianza, apoyo y una asesoría legal meticulosa y acertada. La experiencia fue más que satisfactoria, y nos sentimos respaldados en cada paso del proceso. Para cualquier empresa que enfrente desafíos en responsabilidad contractual, recomendamos ampliamente al Abog. Jaime Andrés y al equipo de Nieto Lawyers.

Alex Suárez, Entre Obras S.A.S.
Rafael Diaz
18:25 14 Aug 23
Gran profesionalidad, siempre atentos a los proceso para conseguir el mejor resultado
Lani Bonilla
00:16 05 Jul 23
Excelentes profesionales , comprometidos con su trabajo , siempre dispuestos a ayudar y trabajar en el caso para lograr el éxito del mismo sin importar el tiempo y las adversidades si se presentan del mismo . Muy buena experiencia en mi caso con los abogados . Mis recomendaciones para una buena y eficaz experiencia en resoluciones de casos en lo que corresponde a su gran labor .
LUZ AIDA Martinez
02:53 01 Jul 23
Está compañía se distingue por la calidad humana, sentido de pertenencia, seriedad y profesionalismo.
Carla Meza Núñez
21:35 16 Jun 23
Encontré mucha amabilidad en este estudio de abogados y siempre resolvieron de manera eficaz nuestros casos de propiedad intelectual.
Estudio Abogados M P
21:29 16 Jun 23
Una Firma de Abogados altamente recomendable, nuestra experiencia fue satisfactoria.
Un despacho de excelentes abogados. Nos ayudaron con temas legales para el Sector Minero y lo resolvieron satisfactoriamente. Estamos muy agradecidos y contentos con el servicio recibido.

Latest News

Firefly_Medical technician in a lab coat and gloves inspecting a barcode on medical device pa 279374
Does your company import, manufacture, or distribute Class III–IIb medical devices in Colombia?
Since 2024, INVIMA has required full compliance with the semantic standard for these products — yet over...
See More

We would love to hear from you

Contact Us

At Nieto Lawyers, we are experts in legal advisory services in regulatory and health law in Colombia. If you need support with matters related to health regulations, licenses, permits, regulatory compliance, or any other legal issue in the sector, we are here to help you.

Send Us a Message

News

Subscribe and receive exclusive content, tips, and updates directly in your inbox.

AVISO DE COOKIES

AVISO DE PRIVACIDAD DE NIETO & NIETO LAWYERS S.A.S.

Por medio de este documento y de conformidad con lo dispuesto por la Ley Estatutaria 1581 de 2012, el artículo 14 del Decreto Reglamentario 1377 de 2013 y demás normas concordantes, NIETO & NIETO LAWYERS S.A.S., identificada con NIT 830.083.908-9, da a conocer a sus clientes, proveedores, empleados, asociados y visitantes de sus plataformas web la existencia de la POLÍTICA DE TRATAMIENTO Y PROTECCIÓN DE DATOS PERSONALES DE LA COMPAÑÍA NIETO & NIETO LAWYERS S.A.S., que les será aplicable al momento de utilizar las referidas herramientas web, realizar comentarios en el blog y/o tener relaciones comerciales, civiles y/o laborales con la empresa, así como la forma de acceder a dicha política y las finalidades del tratamiento de datos personales que se pretende dar.

1. Políticas de tratamiento de la información personal:
NIETO & NIETO LAWYERS S.A.S pone de presente que podrán consultar en cualquier momento la política de tratamiento de datos personales que rige en la empresa, la cual, podrán consultar en todo momento en la página web www.nietolawyers.com.

2. Finalidad del tratamiento de la información personal.
De conformidad con lo expuesto en la POLÍTICA DE TRATAMIENTO Y PROTECCIÓN DE DATOS PERSONALES DE LA COMPAÑÍA NIETO & NIETO LAWYERS S.A.S., la recolección, procesamiento, almacenamiento, tratamiento, verificación, uso, circulación, transferencia y/o transmisión nacional y/o internacional de los datos personales se realiza con el objeto de:

  • Dar cumplimiento a las obligaciones comerciales en el marco de relaciones contractuales con sus clientes, proveedores y empleados.
  • Permitir la identificación y contacto de clientes, proveedores y empleados de NIETO & NIETO LAWYERS, para efectos contractuales y legales.
  • Procesar y asegurar el cumplimiento y entrega de los servicios adquiridos por los clientes de NIETO & NIETO LAWYERS, así como elaborar la facturación correspondiente.
  • Envío de publicidad sobre servicios de NIETO & NIETO LAWYERS.
  • Ofrecimiento público o privado de servicios de NIETO & NIETO LAWYERS.
  • Realizar análisis y perfilamientos de los clientes que permitan definir los servicios que se acomodan a sus gustos y preferencias.
  • Comunicar la realización de actividades y eventos organizados por NIETO & NIETO LAWYERS.
  • Organización del registro de información de proveedores para el envío de órdenes de compra.
  • Comunicación, consolidación, organización, actualización, control, acreditación, aseguramiento, estadística, reporte, mantenimiento, interacción, y gestión de las actuaciones, informaciones y actividades en las cuales se relacionan o vinculan a los proveedores y contratistas con NIETO & NIETO LAWYERS.
  • Gestión administrativa y corporativa de la compañía NIETO & NIETO LAWYERS.
  • Facilitar el uso de las funciones interactivas del sitio web, como la opción de comentar en las publicaciones del blog, en el marco de las normas de privacidad establecidas.

3. Derechos de los titulares de datos personales.
Sin perjuicio de los derechos reconocidos por la Ley 1581 de 2012, el Decreto 1377 de 2013 y de aquellos mencionados en la POLÍTICA DE TRATAMIENTO Y PROTECCIÓN DE DATOS PERSONALES DE LA COMPAÑÍA NIETO & NIETO LAWYERS S.A.S., los titulares de datos personales a los que acceda NIETO & NIETO LAWYERS S.A.S. tendrán, en particular, los siguientes:

  • Acceder en forma gratuita a los datos proporcionados que hayan sido objeto de tratamiento.
  • Conocer, actualizar y rectificar su información frente a datos parciales, inexactos, incompletos, desactualizados, fraccionados, que induzcan a error, desprestigio o a aquellos cuyo tratamiento esté prohibido o no haya sido autorizado.
  • Solicitar prueba de la autorización otorgada.
  • Presentar ante la Delegatura para la Protección de Datos Personales de la Superintendencia de Industria y Comercio (SIC) quejas por infracciones a lo dispuesto en la normatividad vigente.
  • Revocar en cualquier tiempo la autorización y/o solicitar la supresión del dato, siempre que no exista un deber legal o contractual que impida eliminarlos.
  • Abstenerse de responder las preguntas sobre datos sensibles. NIETO & NIETO LAWYERS S.A.S informa que tendrá carácter facultativo las respuestas que versen sobre menores de edad y datos sensibles como aquellos relacionados con el origen racial o étnico, género, orientación sexual o política, convicciones religiosas, pertenencia a sindicatos, asociaciones u organizaciones sociales autorizadas por la Ley, entre otros.

4. Uso de cookies y otras tecnologías de seguimiento.
NIETO & NIETO LAWYERS S.A.S. informa a los usuarios que, al visitar su página web, se recolectará información a través de cookies y otras tecnologías de seguimiento. Estas se utilizan para mejorar la experiencia de navegación, analizar el comportamiento de los usuarios en el sitio web, y facilitar la interacción en la plataforma, como la funcionalidad de comentar en el blog.

Los usuarios tendrán la posibilidad de configurar su navegador para rechazar o aceptar cookies, así como la opción de eliminar cookies previamente almacenadas. En todo momento podrán gestionar las preferencias de cookies, permitiéndoles elegir cuáles permiten y cuáles no, a fin de asegurar un manejo transparente y controlado de la información.