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Lifesciences Compliance Services In Colombia
Optimizing your regulatory journey, we ensure time-efficient and sustained compliance, driving your Life Sciences product to success in Colombia.
Colombia
Artixio serves as a reliable global partner, simplifying your regulatory journey in Colombia. We have a tech-enabled, highly experienced team with local expertise that provides end-to-end support in bringing your Life Sciences product to the Colombian market successfully. We aim to efficiently support our customers right from product conceptualization to market entry and post-marketing surveillance.
Regulatory Authorities In Colombia
INVIMA
- INVIMA regulates the pharmaceuticals, medical devices, biologics, cosmetics, and wellness products in Colombia.
- It ensures that these products comply with all the safety and quality standards set by INVIMA.
- Under INVIMA, all the regulatory procedures of import-export, production, packaging, labeling, distribution, and marketing are carried out.
- Ministerio de Salud y Protección Social regulates the national health policies in Colombia in association with the INVIMA.
- Secretarías de Salud, in association with INVIMA, oversees the surveillance aspect for Life Sciences products in Colombia.
ICA
- ICA is responsible for regulating veterinary products, animal food, animal biologics, and agricultural products in Colombia.
- The quality, safety, and efficacy of these products are ensured by ICA, by regulating the manufacturing, packaging, and marketing procedures.
Ensure Seamless Regulatory Compliance In Colombia with Artixio
We at Artixio provide comprehensive regulatory services, including regulatory affairs, product registration, label, artwork, market access, post-market entry, and maintenance for your Life Sciences product in Colombia. Our dedicated team with 15-30 years of experience provides tailored strategies to ensure easy market access and timely compliance under the stringent regulations of INVIMA. Our regulatory strategies help you easily navigate through the robust regulatory framework of INVIMA and ICA regulations.
Why Trust Artixio with Your Regulatory Journey In Colombia?
Local expertise with 15-20 years of experience in successfully registering and maintaining 2000+ licenses
Direct access to in-house INVIMA regulatory liaisons
KPI based, continual process excellence
Successful Approvals and Ongoing Product Lifecycle Maintenance for 200+ products
End-to-end support from concept to commercialization
Our 15-30 years of experience tech-enabled team with a regulatory intelligence-driven solution ensures sustained compliance in Colombia.
Flexible, strategic, timely, and quality submissions.
ISO 9001:2015, Quality Driven Services Platform
Hybrid-Local-Centralized Support across Regulatory functions
Our Services
Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access
Industries We Serve in the European Union
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
FAQs
How to approach the INVIMA in Colombia, and what are the modes of communication?
The INVIMA has its online portal for any communication known as the SPO system, or through emails and telephone. However, the foreign representatives should appoint a legal representative for communication, as INVIMA does not directly contact the foreign manufacturers.
Are foreign GMP certificates recognized by the INVIMA in Colombia?
Yes, INVIMA recognizes foreign GMP certificates, especially from known health authorities such as the FDA, EMA, PMDA, WHO, and WHO-certified authorities.
What are the reasons for the delay by INVIMA in Life Sciences product approval?
The common reasons for the delay in INVIMA Life Sciences product approval include an incomplete dossier, improper Spanish translation, lack of legal representative documents, incomplete manufacturing, packaging, and labeling details.
What is the fee for Life Sciences product registration with INVIMA in Colombia?
The fees associated with Life sciences product varies from product to product based on their risk level, such as the registration fees for pharmaceuticals ranges from USD 3,000 to 5,000, for medical devices it ranges from USD 500 to 2,000, for biologics and vaccines it ranges from USD 4,000 to 6,000 and for cosmetics and wellness products it ranges from USD 100 to 500.
What is the approval license validity for Life Sciences products in Colombia?
The approval license validity for Life Sciences products is 10 years, and it should be renewed at least 6 months before its expiry, or else the product needs to be registered again as a new product.
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