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

🇱🇦 Regulatory and Research Services for Laos

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, provide complete regulatory and research services for pharmaceutical, nutraceutical, herbal, traditional medicine, food supplement, cosmetic, and veterinary companies entering the Lao PDR market.

Our services strictly follow FDD (Food & Drug Department) rules, ASEAN guidelines (ACTD/ACTR), and WHO/ICH international standards.

📘 Regulatory Services for Laos

🇱🇦 Regulatory & Product Registration Support – Laos (ASEAN)

We support companies through all regulatory steps to enter the Lao market in compliance with:

✔ FDD – Food and Drug Department (Ministry of Health, Lao PDR)
✔ Department of Food Safety & Quality (FSQ) – supplements/foods
✔ Department of Traditional Medicine (DTM) – herbal/Traditional products
✔ ASEAN ACTD/ACTR
✔ Lao Cosmetic Registration Regulations
✔ WHO/ICH Guidelines

📘 Product Registration Services

• Laos/ASEAN Dossier Preparation & Product Registration

– Preparation of ACTD-compliant dossiers for pharmaceuticals (Rx/OTC)
– National registration with FDD
– Food supplement & nutraceutical registration
– Herbal & traditional medicine registration (DTM)
– Cosmetic product registration in line with ASEAN Cosmetic Directive
– Veterinary product registration (Ministry of Agriculture & Forestry)
– Ingredient validation according to Lao prohibited/restricted lists

• Laos Label & Packaging Compliance

– Mandatory Lao language labeling (with optional English)
– Compliance with FDD labeling requirements
– Review of claims, warnings, directions for use
– Packaging, IFU & artwork development

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

– API documentation in ACTD/CTD format
– Adapting US/EU/WHO DMFs for Laos submission
– GMP documentation per WHO/PIC/S standards
– Stability & quality data for Laos import approval

⚗️ Bioequivalence (BE) Study Support – Laos

– BE protocols per ASEAN + WHO + ICH guidelines
– Acceptance of foreign BE studies (India, EU, US, ASEAN)
– Full BE report preparation for FDD review
– Biowaiver justification (BCS Class I/III)

🔬 Analytical Method Validation (AMV) Services

– AMV following ICH Q2(R2)
– Assay, impurities, dissolution & stability validations
– AMV protocol + raw data + final validation report
– QC support for Laos-local distributors

🧾 Regulatory Consultancy & Compliance – Laos

– Product classification support
– Local importer/authorized representative (AR) guidance
– GMP/GDP compliance for Laos registration
– Variations, renewals, post-marketing requirements
– Monitoring FDD & ASEAN guideline updates

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

💊 Formulation Development

– Tablets, capsules, syrups, powders, injectables
– ASEAN Zone IVb (Hot & Humid) stability studies
– Formulation optimization for Lao/ASEAN climate & regulations

🧫 Analytical R&D Services

– Assay, impurity profiling, dissolution
– QC method development & validation
– Stability studies: real-time + accelerated

📑 Product Development Reports (PDRs)

– ACTD/CTD-compliant PDR preparation
– Includes manufacturing, analytical & stability details

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical study documents as per ICH-GCP (E6)
– Toxicology submission based on OECD guidelines
– Cosmetic safety documents per ASEAN requirements
– Herbal/traditional safety documentation (DTM-compliant)

🌏 Why Choose Us for the Laos Market

• Experts in FDD, FSQ, DTM & ASEAN regulatory systems
• End-to-end dossier preparation & regulatory support
• Strong experience across ASEAN, GCC, EU, US & ROW
• Fully compliant CTD/ACTD preparation
• Fast registration through correct product classification and documentation

📘 Regulatory & Dossier Documentation – Laos/ASEAN

Hashtags – Laos & ASEAN
#DossierLaos #RegulatoryLaos #FDDLaos #ACTD #CTDLaos
#NutraceuticalLaos #CosmeticsLaos #HerbalLaos #PharmaLaos
#StabilityStudiesASEAN #PharmaComplianceASEAN #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – Laos

#BEStudiesASEAN #BioequivalenceLaos #AMV #AssayValidation
#DissolutionValidation

🧪 Technology Transfer & Safety – Laos

#TechnologyTransferASEAN #MethodTransfer #MSDS
#PharmaTechTransferLaos