Specialists in:
Synthetic drugs Biologics Medical devices Cosmetics Orphan drugs
Service portfolio · Colombia · INVIMA

Pharmaceutical regulatory services in Colombia — health registrations, medical devices & more

We manage the complete regulatory process before INVIMA for chemically synthesized drugs, biologics, medical devices, cosmetics, and orphan drugs. We accompany national and international companies from initial assessment to approval resolution — and beyond.

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Core service

Health registration of drugs before INVIMA

The drug health registration process in Colombia is the most complex procedure in the regulatory portfolio. It requires precise technical preparation, knowledge of INVIMA's system, and the ability to respond to requirements. We manage the entire process — from start to finish.

Chemical synthesis Generic and with pharmacological evaluation before the Review Commission
Biologics and biosimilars Biotechnological with complete dossier before INVIMA
Registration modifications Quality, safety, efficacy, and legal aspects
Specialized consulting Experts for complex registrations and critical situations
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All our services

Complete regulatory portfolio

Every product and every regulatory situation has its specific path. Find the service you need.

Medical devices

Health registration of medical devices

Classification and registration before INVIMA for risk I, II, III, and IV devices. In vitro diagnostic reagents and technical and legal modifications.

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Orphan drugs

Orphan drugs and vital unavailable medicines

We facilitate access to essential medicines not available in the Colombian market — global sourcing, import management, and case-by-case follow-up.

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Import

Import and commercialization of pharmaceutical specialties

Comprehensive management of the pharmaceutical supply chain in Colombia — import, specialized storage, and national distribution with full regulatory compliance.

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Regulatory intelligence

Regulatory intelligence for the pharmaceutical industry

We keep your company informed about regulatory changes in Colombia — early alerts, impact analysis, strategic reports, and international benchmarking.

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Need another regulatory service? We also manage health registration modifications, renewals, quality control with Qualified Person (QP), pharmaceutical brand registration, and hourly regulatory consulting.

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Exclusive benefit

Save up to USD 27,000 in INVIMA fees

When GRA acts as the health registration holder in Colombia — with your authorization — official INVIMA fees are reduced to zero. For biological and biosimilar products, this represents savings of up to USD 27,000 compared to standard registration costs.

Legal note: Applies to biological and biosimilar products. Requires written authorization from the product holder. Terms and conditions apply.
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Why choose us

What makes us different

15+

Years navigating Colombian regulation

We know every step, every requirement, and every detail that keeps your product moving within the INVIMA system.

100%

Bilingual team — Spanish & English

No translation gaps. We work with international clients in English and manage all communication with INVIMA in Spanish.

USD 27,000

Saved in regulatory fees

As the health registration holder in Colombia, INVIMA fees are reduced to zero for biologics and biosimilars.

0

External systems processing your data

All analysis runs on our own systems. Your dossiers never touch external servers or cloud-based AI.

Ready to manage your registration before INVIMA?

Tell us the product type and manufacturing country. We'll respond in less than 24 hours with the recommended regulatory pathway and a clear budget.

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