ANDEAN REGION

Regulatory Affairs Management Services in the Andean Region

The Andean region, encompassing countries such as Colombia, Ecuador, Peru, and Bolivia, offers immense business opportunities. It goes without saying that operating in these markets requires a deep understanding of the complex regulatory landscape.

Rebexa Group works with healthcare clients in the U.S., Canada, Europe, and other countries to support their regulatory affairs projects in Ecuador, Colombia, Peru, and Venezuela.

What is the Andean Regulatory Landscape?

The Andean region boasts a rich tapestry of regulatory frameworks, with each country having unique regulations, requirements, and approval processes.

Navigating these complexities demands in-depth knowledge of local legislation and a keen eye for regulatory updates and changes.

Our regulatory affairs management services are pivotal in helping businesses stay compliant and thrive in this vibrant market.

To manage regulatory affairs programs in Venezuela, Rebexa Group is the premier partner in the region for medical companies.

To market a product or device in Venezuela, the parent company must register the product with the Ministry of the Popular Power for Health and/or Ministry of Agriculture and Lands (INSAI).

Country Information

Capital: Caracas
Population: 31,028,337
Health Agency: Ministry of the Popular Power for Health
Pharmaceuticals Regulations and Requirements in Venezuela
Medical Devices Regulations & Requirements in Venezuela
Veterinary Products Regulations & Requirements in Venezuela

Please contact us to learn about our regulatory affairs services in Venezuela.

Looking for Regulatory Guidance?

Receive comprehensive details for product registration and understand the regulatory environment governing your target market. Fill out the form below to connect with our experts and get the insights you need.

Get in Touch Now and Simplify Your Compliance Journey!

Rebexa Group serves medical devices, veterinary, and pharmaceutical companies seeking regulatory affairs management in Colombia. Rebexa Group’s comprehensive service offerings make them the leading partner in the country.

Commercializing a health product in Colombia requires product registration with the Ministry of Health (INVIMA) or Ministry of Agriculture and Rural Development (ICA).

Country Information

Capital: Bogotá
Population: 48,747,632
Health Agency: Ministry of Health
Pharmaceuticals Regulations and Requirements in Colombia
Medical Devices Regulations & Requirements in Colombia
Veterinary Products Regulations & Requirements in Colombia

Please contact us to learn about our regulatory affairs services in Colombia.

Looking for Regulatory Guidance?

Receive comprehensive details for product registration and understand the regulatory environment governing your target market. Fill out the form below to connect with our experts and get the insights you need.

Get in Touch Now and Simplify Your Compliance Journey!

Rebexa Group helps healthcare companies obtain country approval to sell their products in Ecuador through our legal entity, Rebexa Representaciones S.A. Rebexa Group is the leading partner for regulatory affairs management.

Registration Representation in Ecuador

Ecuador requires product manufacturers to have, or authorize, a local legal entity to register its products. Rebexa Group provides our clients the opportunity to comply with this requirement through one contact point, independent of its distributors, ensuring cost efficiency and full control of its registrations and intellectual property.

As local agents, we take care of all the necessary procedures related to registered products and comply with every requirement and established government regulation, providing our clients the trust and legal formality these processes demand. We act as the local contact between companies and the Ministry of Public Health (ARCSA) and/or Ministry of Agriculture, Livestock and Fisheries (AGRO CALIDAD).

Country Information

Capital: Quito
Population: 16,298,217
Health Agency: Ministry of Health
Pharmaceuticals Regulations and Requirements in Ecuador
Medical Devices Regulations & Requirements in Ecuador
Veterinary Products Regulations & Requirements in Ecuador

Please contact us to learn about our regulatory affairs services in Ecuador.

Looking for Regulatory Guidance?

Receive comprehensive details for product registration and understand the regulatory environment governing your target market. Fill out the form below to connect with our experts and get the insights you need.

Get in Touch Now and Simplify Your Compliance Journey!

Rebexa Group is your premier partner for regulatory affairs management in Peru. If your medical product requires out sourced compliance services in Peru, Rebexa Group can assist you.

Regulations in Peru require pharmaceutical, medical devices and veterinary products to be registered with the Ministry of Health (DIGEMID) or Ministry of Agriculture & Irrigation (SENASA).

Country Information

Capital: Lima
Population: 31,151,643
Health Agency: Ministry of Health of Peru
Pharmaceuticals Regulations and Requirements in Peru
Medical Devices Regulations & Requirements in Peru
Veterinary Products Regulations & Requirements in Peru

Please contact us to learn about our regulatory affairs services in Peru.

Looking for Regulatory Guidance?

Receive comprehensive details for product registration and understand the regulatory environment governing your target market. Fill out the form below to connect with our experts and get the insights you need.

Get in Touch Now and Simplify Your Compliance Journey!

Expertise in Specialized Industries

Different industries face distinct regulatory challenges. Whether it is pharmaceuticals, medical devices, cosmetics, food, and beverages, or any other sector, our regulatory affairs management services cater to the unique requirements of each industry.

The team at Rebexa Group consists of subject matter experts who possess comprehensive knowledge of sector-specific regulations, enabling businesses to navigate complex regulatory landscapes with confidence.

Compliance with regulatory requirements is a non-negotiable aspect of sustainable business operations. In the Andean region, regulatory frameworks are subject to frequent updates and revisions.

Our dedicated team stays abreast of these changes, conducting comprehensive audits and risk assessments to ensure our clients remain compliant.

By proactively monitoring regulatory developments, we provide valuable insights and guidance to mitigate potential risks and optimize business continuity.

Resolve your Regulatory & Compliance issues!

Receive comprehensive details for product registration and understand the regulatory environment governing your target market. Fill out the form below to connect with our experts and get the insights you need.

Contact Us Today for Expert Assistance!