Legal Holder and Representation
We act as the local holder for your product registrations in Colombia, a key role for foreign companies and for cosmetics regulated under the Andean Community framework.
Bogota, Colombia · Since 2008
Your strategic partner in regulatory affairs for the Colombian market.
We run your INVIMA regulatory function as an embedded expert team. Regulatory BPO for Colombian and international companies entering or operating in the market.
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Years in operation
0+
INVIMA registrations managed
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Sectors with full service
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Response time
Zimmer BiometMerckNovo NordiskBoehringer IngelheimAbbottConmedBeckman CoulterMicroportAlma LasersGRISIValeantZimmer BiometMerckNovo NordiskBoehringer IngelheimAbbottConmedBeckman CoulterMicroportAlma LasersGRISIValeant
Core service · 01
End-to-end management of regulatory affairs.
We turn regulatory obligation into competitive advantage. We operate as the managers of your regulatory area so your products can continue moving through the market.
Areas of intervention
Hosting
Legal Holder and Representation
We act as the local holder for your product registrations in Colombia, a key role for foreign companies and for cosmetics regulated under the Andean Community framework.
Lifecycle Management
We monitor registration validity, manage technical and legal changes, and prepare renewals on time to avoid sales interruptions.
Regulatory Strategy
We define the most efficient path to compliance and optimize resources before any submission is filed with INVIMA.
Expert Technical Liaison
We speak the technical language of manufacturers and manage documentation in English or Spanish to build strong dossiers.
Response to Authority Requests
We lead the technical defense of submissions, coordinate evaluator meetings, and resolve complex questions during review.
Supplementary service · 02
Quality assurance
and compliance.
To compete in today's market, your company must demonstrate robust quality systems that back your processes. We support you in the diagnosis and implementation to avoid health authority sanctions.
Implementation and Auditing
Supplier Management
Due Diligence
Corporate Training
Coverage · 03
Three sectors with full service,
two with specialized training.
Focused coverage by design: we deepen where our expertise builds real value and deliver expert training where compliance is critical.
Full service
Medical devices
From orthopedic implants and electromechanical devices to consumables and software as a medical device. Full management of product registrations and quality assurance.
Class I · IIa · IIb · III
Import · Local manufacturing
Full service
Cosmetics
Mandatory Health Notification (NSO) under Andean Community regulations. We act as legal holders for foreign companies.
NSO · CAN
Hosting available
Full service
Homecare, hygiene and absorbents
Household and industrial cleaning products, household pesticides, personal hygiene absorbents and related products.
NSO · Health permit
Local production · Imported
Training only · no regulatory management
Pharmaceuticals
Specialized training in current pharmaceutical regulations, GMP and GDP.
Food
Corporate workshops and training in health compliance for the food industry.
Track record · 04
18 years as the regulatory engine of
leading companies.
Our experience is built on results delivered to demanding national and multinational companies.
0
years
of continuous track record
+0
companies
national and multinational
0
countries
of origin represented
0+
registrations
managed with INVIMA
01Medical devices18 clients
- Zimmer Biomet
- Conmed Corporation
- Microport Orthopedics
- Alma Lasers
- Beckman Coulter
- BOWA-electronic
- Regen Lab
- Menicon
- Mark'ennovy
- Rudolf Riester
- Noris Medical
- Movmedix L.A.R.S.
- Fengh Medical
- DEBx Medical
- Bain Medical
- Nikkiso Medical
- Synimed
- Younger Optics
- Zimmer Biomet
- Conmed Corporation
- Microport Orthopedics
- Alma Lasers
- Beckman Coulter
- BOWA-electronic
- Regen Lab
- Menicon
- Mark'ennovy
- Rudolf Riester
- Noris Medical
- Movmedix L.A.R.S.
- Fengh Medical
- DEBx Medical
- Bain Medical
- Nikkiso Medical
- Synimed
- Younger Optics
02Cosmetics · Homecare and hygiene7 clients
- GRISI HNOS
- Ilko Arcoaseo · Virutex
- Farmaretail
- Amenigraf
- Brand New for Lige
- CI Evolution Brands
- Laboratorio Vivians
- GRISI HNOS
- Ilko Arcoaseo · Virutex
- Farmaretail
- Amenigraf
- Brand New for Lige
- CI Evolution Brands
- Laboratorio Vivians
03Pharmaceuticals & food · Training11 clients
- Abbott Laboratories
- Boehringer Ingelheim
- Merck Colombia
- Novo Nordisk
- Laboratorios Legrand
- Liminal Therapeutics
- Kamada
- Valeant
- El Pozo Alimentación
- Grupo Benatto
- Seitenbacher
- Abbott Laboratories
- Boehringer Ingelheim
- Merck Colombia
- Novo Nordisk
- Laboratorios Legrand
- Liminal Therapeutics
- Kamada
- Valeant
- El Pozo Alimentación
- Grupo Benatto
- Seitenbacher
Alliances · 05
Industry references.
Our expertise has positioned us as trusted advisors for international entities and industry associations.
01 / enlace
KOTRA
Korean Business Council
Specialized consulting for Korean entrepreneurs looking to enter the Colombian market.
02 / enlace
Economic Mission of Israel
Embassy · Bogota
Support for Israeli companies in their entry into the Colombian health and regulatory system.
03 / enlace
Workshop ABIMO
Brazilian Health Devices
Expert firm selected to advise attendees on Colombian sanitary registration legislation.
04 / enlace
Cosmeet LatAm
Ministry of Commerce · Turkey · IKMIB
Participation as expert consultants on NSO regulations at events for cosmetics exporters.
Next step
Ready to integrate an expert regulatory division into your organization?
We schedule a no-cost initial assessment, review your portfolio, and define a clear compliance path with INVIMA.
Offices
Av. El Dorado 68C-61 Of. 830-1
Torre Central Building · Bogota D.C.
Phone / WhatsApp
+57 310 3155123
Email
info@vexproconsultores.com