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

🇧🇳 Regulatory and Research Services for Brunei Darussalam

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

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

Our services comply with BDR, MOH Brunei, ASEAN Guidelines, Brunei Halal Authority, and WHO/ICH requirements.

📘 Regulatory Services for Brunei

🇧🇳 Regulatory & Product Registration Support – Brunei (ASEAN)

We support companies through the complete Brunei regulatory pathway in accordance with:

✔ Brunei Darussalam Medicines Control Authority (BDR)
✔ Drug Regulatory Authority – Ministry of Health
✔ ASEAN ACTD/ACTR Guidelines
✔ Brunei Halal Certification Authority (if applicable)
✔ WHO/ICH Q/S/E Guidelines
✔ Medicines (Licensing, Standard & Control) Regulations

📘 Product Registration Services

• Brunei Dossier Preparation & Product Registration

– Preparation of ACTD-compliant dossiers for pharmaceuticals (Rx/OTC)
– National registration under Brunei’s MOH drug regulatory framework
– Food supplement & nutraceutical registration
– Herbal & traditional medicine registration
– Cosmetic notification/registration under Brunei Cosmetic Regulations
– Halal requirement assessment (if product category requires Halal approval)
– Ingredient compliance based on BDR prohibited & restricted lists, ASEAN cosmetic directives, and food supplement regulations

• Brunei Label & Packaging Compliance

– Mandatory English and/or Malay labeling
– Label compliance with Brunei MOH labeling rules
– Review of claims, allergen statements, dosage instructions
– Packaging artwork, IFU & leaflet development

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

– API documentation in CTD/ACTD format
– CEP/US DMF bridging acceptable
– GMP evidence (PIC/S, WHO, EU, US GMP recognized)
– Stability, impurity & quality documentation for Brunei approval

⚗️ Bioequivalence (BE) Study Support – Brunei

– BE study design per ASEAN + WHO + ICH guidelines
– Acceptance of BE studies from ASEAN, India, EU, US (if accredited)
– Complete BE report preparation for BDR submission
– BCS-based biowaiver support (Class I/III APIs)

🔬 Analytical Method Validation (AMV) Services

– AMV according to ICH Q2(R2)
– Assay, impurities, dissolution, RS & stability validation
– Preparation of AMV protocols + final validation reports
– QC documentation for Brunei drug submissions

🧾 Regulatory Consultancy & Compliance – Brunei

– Product classification:
✔ Medicine
✔ Food Supplement
✔ Cosmetic
✔ Herbal/Traditional
✔ Veterinary
– Local agent/import license guidance in Brunei
– GMP/GDP compliance support
– Post-registration maintenance: variations, renewals, safety reports
– Monitoring Brunei MOH/BDR regulatory updates

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

💊 Formulation Development

– Tablets, capsules, syrups, powders, injectables
– Stability testing for ASEAN Zone IVb (Hot & Humid)
– Formulation optimization for Brunei & ASEAN markets

🧫 Analytical R&D Services

– Assay, dissolution, impurity profiling
– QC method development & validation
– ICH-compliant stability studies

📑 Product Development Reports (PDRs)

– PDRs prepared in ACTD/CTD format
– Includes manufacturing process, analytical results, stability summaries

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial documentation per ICH-GCP (E6)
– Toxicology dossiers per OECD standards
– Cosmetic safety evaluation documentation
– Halal compliance documentation (if applicable)

🌏 Why Choose Us for the Brunei Market

• Experts in BDR, MOH Brunei, ASEAN regulatory systems
• End-to-end regulatory, documentation & compliance support
• Strong experience with ASEAN, GCC, EU, US & ROW markets
• Compliant and efficient ACTD/CTD dossier preparation
• Product-specific regulatory strategies for pharmaceuticals, supplements, and cosmetics in Brunei

📘 Regulatory & Dossier Documentation – Brunei

Hashtags – Brunei & ASEAN
#DossierBrunei #RegulatoryBrunei #BDR #MOHBrunei
#CTDBrunei #ACTD #PharmaBrunei #CosmeticsBrunei
#FoodSupplementBrunei #HerbalBrunei #PharmaASEAN
#StabilityStudiesASEAN #BMR #MFR