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

🇦🇫 Regulatory and Research Services for Afghanistan

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, provide comprehensive regulatory and research services for pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies entering the Afghanistan market.

Our services comply with the National Medicine and Healthcare Products Authority, Ministry of Public Health, ANSA, and WHO/ICH guidelines.

📘 Regulatory Services for Afghanistan

🇦🇫 Regulatory & Product Registration Support – Afghanistan

We guide companies through every step of regulatory submission and product approval in Afghanistan according to:

✔ National Medicine and Healthcare Products Authority (NMPA), Afghanistan
✔ Ministry of Public Health (MoPH)
✔ National Medicines Import & Export Rules
✔ ANSA – Afghanistan National Standards Authority
✔ WHO/ICH guidelines (accepted for quality & safety)

📘 Product Registration Services

• Afghanistan Dossier Preparation & Product Registration

– Preparation of Afghanistan-compliant dossiers (CTD-like format accepted)
– Registration of pharmaceuticals (Rx/OTC)
– Herbal & Unani products registration (Category-wise)
– Nutraceutical & food supplement registration
– Cosmetic product registration with NMPA
– Product stability, safety & efficacy document preparation
– Ingredient-based acceptability evaluation according to MoPH rules

• Afghanistan Label & Packaging Compliance

– Mandatory Dari / Pashto and English labels
– Compliance with MoPH labeling regulations
– Verification of therapeutic claims, warnings, batch information
– Packaging, IFU & artwork preparation

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

– API documentation preparation in CTD/WHO format
– Manufacturer GMP documentation as required by MoPH
– Validation of API source, COA, stability & safety data
– Support for API imports into Afghanistan

⚗️ Bioequivalence (BE) Study Support – Afghanistan

– BE study document preparation as per MoPH & WHO guidelines
– Acceptance of international BE studies (India, EU, US) with bridging
– Biowaiver justification for BCS Class I/III APIs
– BE report compilation for Afghanistan submissions

🔬 Analytical Method Validation (AMV) Services

– AMV documentation as per ICH Q2(R2)
– Assay, impurities, dissolution & stability validation
– Preparation of AMV protocol + final validation report
– QC method support for Afghanistan import approval

🧾 Regulatory Consultancy & Compliance – Afghanistan

– Product classification:
✔ Pharmaceutical
✔ Herbal & Unani
✔ Nutraceutical
✔ Cosmetic
✔ Veterinary
– Import/Export license support through MoPH
– GMP/GDP compliance assistance for imports
– Post-approval support: variations, renewals, re-registrations
– Market surveillance & compliance (per NMPA rules)

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

💊 Formulation Development

– Tablets, capsules, syrups, powders, injectables
– WHO Zone IV (Hot & Humid) stability study support
– Formulation optimization for Afghan climatic conditions

🧫 Analytical R&D Services

– Assay, impurities, dissolution, stability testing
– QC method development & validation
– Stability studies (real-time & accelerated)

📑 Product Development Reports (PDRs)

– Preparation of PDR in CTD/WHO format
– Includes manufacturing process, analytical methods & stability data

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial protocols & reports (WHO-GCP compliant)
– Toxicology data compilation per OECD guidelines
– Cosmetic safety documentation & ingredient assessment

🌏 Why Choose Us for the Afghanistan Market

• Deep expertise in MoPH, NMPA, ANSA regulatory systems
• End-to-end regulatory & documentation support for imports
• Acceptance of WHO/ICH-compliant data reduces approval time
• Experience with markets across Asia, EU, GCC, US & ROW
• Tailored strategies for herbal, nutraceutical, pharmaceutical & cosmetic products in Afghanistan

📘 Regulatory & Dossier Documentation – Afghanistan

Hashtags – Afghanistan Market
#DossierAfghanistan #RegulatoryAfghanistan #MoPH #NMPA
#PharmaAfghanistan #CosmeticsAfghanistan #FoodSupplementAfghanistan
#HerbalProductAfghanistan #VeterinaryAfghanistan
#PharmaComplianceAsia #CTD #DMF #StabilityStudies #BMR #MFR

⚗️ Bioequivalence & Analytical Services – Afghanistan

#BEStudies #BioequivalenceAfghanistan #AMV #AssayValidation
#DissolutionValidation #PharmaAnalysis

🧪 Technology Transfer & Safety – Afghanistan

#TechnologyTransfer #AnalyticalTransfer #MethodTransfer
#MSDS #PharmaTechTransfer