Regulatory And Research Services for Regulatory-Services-Coverage-by-Colombia-Market

🇨🇴 Regulatory and Research Services for Colombia

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, offer complete regulatory and research services for pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies entering the Colombian market.

Our services comply with INVIMA, the Ministry of Health, Colombian decrees, and global WHO/ICH standards.

📘 Regulatory Services for Colombia

🇨🇴 Regulatory & Product Registration Support – Colombia

We assist companies at every regulatory stage under:

✔ INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos
✔ Ministry of Health & Social Protection
✔ Regimen of Registro Sanitario
✔ Decree 677/1995, Decree 780/2016
✔ WHO/ICH Q/S/E Guidelines

Colombia uses CTD-like Modules 1–5 for pharmaceutical registration.

📘 Product Registration Services

• Colombia Dossier Preparation & Product Registration

– Pharmaceutical registration (Rx/OTC) with INVIMA
– Biologicals, generics, phytopharmaceuticals & homeopathic registration
– Food supplement / nutraceutical notification (Suplementos Dietarios)
– Cosmetic product registration (Notification with INVIMA)
– Veterinary products registration
– Ingredient compliance with Colombian restricted/prohibited lists
– Complete submission until Registro Sanitario approval

• Colombia Label & Packaging Compliance

– Mandatory Spanish labeling
– Compliance with INVIMA & Ministry of Health labeling rules
– Verification of therapeutic claims, allergens, warnings, expiry & batch info
– IFU, artwork & packaging development per Colombian regulations

📗 Drug Master File (DMF) / API Documentation – Colombia

– DMF/ASMF in CTD/INVIMA-compliant format
– CEP / EDQM / US DMF bridging support
– GMP Certification support (mandatory for manufacturing sites)
– API impurity, stability & safety documentation
– Import permit support via INVIMA & Customs (DIAN)

⚗️ Bioequivalence (BE) Study Support – Colombia

– BE protocols based on INVIMA + ICH guidelines
– Coordination with Colombia-accredited CROs
– Acceptance of foreign BE studies (EU/US/India) with bridging
– Biowaiver support for BCS I/III APIs
– Complete BE reporting for INVIMA submission

🔬 Analytical Method Validation (AMV) Services

– AMV as per INVIMA + ICH Q2(R2)
– Assay, impurities, dissolution & stability validation
– Submission-ready AMV protocols + raw data + validation reports
– Analytical method transfer documentation for Colombia QC labs

🧾 Regulatory Consultancy & Compliance – Colombia

– Classification: Drug / Supplement / Cosmetic / Herbal / Homeopathic / Veterinary
– INVIMA online system filing support (SIC / SISPRO / PISIS)
– GMP, GDP & pharmacovigilance compliance
– Renewals, variations, PSUR & lifecycle maintenance
– Monitoring regulatory updates from INVIMA & Ministry of Health

🧪 Research & Development (R&D) Services – Colombia Market

💊 Formulation Development

– Tablets, capsules, liquids, injectables, powders
– Stability studies for tropical climate (Zone IVb)
– Colombia-specific excipient & contaminant requirements

🧫 Analytical R&D Services

– Method development, assay, impurity testing
– Dissolution, stability studies (real-time & accelerated)
– Analytical validation per ICH/INVIMA

📑 Product Development Reports (PDRs)

– PDR prepared in Colombian CTD/Module format
– Includes formulation, QC testing, process & stability summaries

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial documentation per ICH-GCP (E6)
– Submissions for INVIMA clinical trial authorization
– Toxicology risk assessment per OECD
– Cosmetic safety assessments in compliance with INVIMA cosmetic rules

🌏 Why Choose Us for the Colombia Market

• Extensive expertise with INVIMA regulatory systems
• End-to-end dossier preparation, submission & regulatory follow-up
• Strong experience with Latin American regulatory frameworks
• Fast and compliant CTD/DMF/AMV preparation
• Complete support across pharmaceuticals, supplements & cosmetics

📘 Regulatory & Dossier Documentation – Colombia

Hashtags – Colombia Market
#DossierColombia #INVIMA #PharmaColombia
#CosmeticsColombia #SupplementsColombia #HerbalColombia
#VeterinaryColombia #CTDColombia #DMFColombia
#StabilityStudies #BMR #MFR #LatinAmericaRegulation

⚗️ Bioequivalence & Analytical Studies – Colombia

#BEStudiesColombia #BioequivalenceColombia #AMV
#DissolutionValidation #AssayValidation

🧪 Technology Transfer & Safety – Colombia

#TechnologyTransferColombia #MethodTransfer #MSDS
#PharmaTechTransferColombia