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

Experts in pharmaceutical health registration in Colombia — with hands-on experience inside INVIMA

Global Regulatory Affairs is a Colombian regulatory consulting firm specialized in health registrations for pharmaceuticals, biologics, medical devices, and cosmetics with INVIMA. We support local and international companies with a team that knows the Colombian regulatory system from the inside.

GRA by the numbers

15+ years navigating Colombian regulation

15+
years of experience in pharmaceutical regulatory affairs in Colombia
5
biologics and biosimilars approved by INVIMA
100+
health registrations successfully completed with INVIMA
100%
bilingual team — Spanish and English
Leadership

Led by someone who knows INVIMA from the inside

Global Regulatory Affairs is led by a Pharmaceutical Chemist with a Master's in Total Quality Management and over 10 years of experience working directly at INVIMA.

That insider track record is a real differentiator — our experts understands the evaluation processes, the criteria of the Review Committee, and the patterns of requirements that determine whether a file moves forward quickly or gets delayed for months. That expertise is what we apply to every filing we manage for our clients.

Team specialties:

  • Health registration for pharmaceuticals — chemical synthesis and biologics
  • Pharmaceutical law and trademark registration with SIC
  • Regulatory data analysis and regulatory intelligence
  • Institutional relations and regulatory strategy
Our story

Why Global Regulatory Affairs exists

Colombia has one of the most demanding health registration systems in Latin America. For an international company looking to enter the Colombian market, navigating INVIMA without a local partner with real experience can mean years of delays and unnecessary costs.

Global Regulatory Affairs was created to solve exactly that problem — to be the bridge between the local and international pharmaceutical industry and the Colombian regulatory system. With a bilingual team, deep technical knowledge, and direct experience inside INVIMA, we turn a complex process into a clear and predictable path for our clients.

Today we support companies from India, the United States, Europe, and Colombia in their regulatory processes — from the initial registration through the amendments and renewals that keep their products on the market.

Why choose us

What makes us different

15+
Years navigating Colombian regulation
100%
Bilingual team — Spanish and English
USD 27,000
Saved in INVIMA regulatory fees
0
External systems processing your data
International reach

We work with companies from around the world

Our clients include Colombian labs, international pharmaceutical companies, and medical device manufacturers looking to access the Colombian and Latin American markets.

Countries our clients come from:

Colombia India United States Germany Switzerland Ireland France Mexico

What they look for in GRA:

A team that speaks their language — literally. A team that understands their product, knows the Colombian system, and has the technical capability to manage the entire process without them having to understand every detail of INVIMA.

Ready to manage your registration with INVIMA?

Tell us the type of product and the country of manufacture. We will respond in less than 24 hours with the recommended regulatory pathway and a clear estimate.

Request a quote Write via WhatsApp
Response in less than 24 hours No-obligation estimate