Specialists in:
Synthetic drugs Biologics Medical devices Cosmetics Orphan drugs
Regulatory services · Colombia · INVIMA

Sanitary registration in Colombia — pharmaceuticals, medical devices & biologics

We manage the full INVIMA registration process in Colombia for pharmaceuticals, biologics, medical devices and cosmetics. From dossier preparation to final approval — bilingual team, 15+ years of experience working with international companies from India, the US and Europe.

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15+
years of regulatory experience in Colombia
5
biologics approved before INVIMA
70+
post-approval modifications completed
Our services

Full regulatory management in Colombia

We support every stage of the regulatory process in Colombia — from first registration to post-approval modifications and specialized services.

Core service

Pharmaceutical sanitary registration before INVIMA

We manage the full registration process — technical dossier preparation, filing, response to regulatory requirements and follow-up until approval.

Chemical synthesis Generic and with pharmacological evaluation
Biologics & biosimilars Biotechnological products before INVIMA
Post-approval modifications Quality, safety, efficacy and legal changes
Expert consulting Specialized support for complex registrations
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Medical devices

Medical device registration in Colombia

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

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Orphan medicines

Orphan drugs & unavailable vital medicines

We facilitate access to essential medicines unavailable in the Colombian market — global sourcing, import management and case-by-case follow-up.

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Importation

Pharmaceutical importation & commercialization

Full pharmaceutical supply chain management in Colombia — importation, specialized storage and national distribution with complete regulatory compliance.

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Regulatory intelligence

Regulatory intelligence for the pharma industry

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

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Looking for another regulatory service? We also handle pharmaceutical trademark registration, Qualified Person (QP) quality control, cosmetics registration and hourly regulatory consulting.

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Why GRA

What makes us different

We don't just process paperwork. We build clear regulatory pathways so your product reaches the Colombian market without unnecessary roadblocks.

15+
Years navigating Colombian regulation
The INVIMA process has its complexities — but we know every step, every requirement, and every detail that keeps your product moving. Our experience turns a complex system into a clear, manageable path.
100%
Bilingual team — Spanish & English
No translation gaps. No misunderstandings. Our team works directly with international clients in English while managing all INVIMA communications in Spanish. Nothing gets lost in translation.
USD 27,000
Saved in INVIMA regulatory fees
When GRA acts as the sanitary registration holder in Colombia — with your authorization — INVIMA fees drop to zero. For biologic and biosimilar products, this represents savings of up to USD 27,000 compared to standard registration costs.
Applies to biologic and biosimilar products. Requires written authorization from the product owner. Terms and conditions apply.
0
External systems processing your data
Regulatory dossiers contain your most sensitive intellectual property. All analysis runs on our own systems. Your files never touch external servers or cloud-based artificial intelligence systems.
GRA Data Protocol

Your confidential data stays confidential

Pharmaceutical regulatory dossiers contain your most sensitive intellectual property — formulations, clinical data, manufacturing processes. We take that seriously. All analysis runs locally on our own systems. No cloud uploads. No third-party AI processing. Ever.

1
Encrypted transfer
Client shares product data through an encrypted, secure channel.
2
Local processing only
All analysis runs entirely on GRA's own systems — never on external servers.
3
Regulatory strategy built internally
Our team builds your regulatory strategy using data science techniques applied locally.
4
No third-party sharing
Your data is never shared with third parties, cloud platforms or AI systems — not ChatGPT, not Claude, not any external tool.
5
Full client ownership
You retain full ownership of all information, analyses and regulatory strategy at all times.

Our protocols meet the standards required by European pharmaceutical clients operating under GDPR — and exceed what most regulatory consultancies in Colombia offer.

Want to know more about how we protect your data? → Talk to our team
How we work

Two stages, one team

Pre-approval

We manage the full process to obtain your sanitary registration — dossier preparation, filing and follow-up before INVIMA until approval.

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Post-approval

We keep your registration current and up to date — technical and legal modifications, renewals and any post-approval changes your product requires.

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Ready to enter the Colombian market?

Tell us about your product. We'll respond within 24 hours with a clear regulatory path forward.

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