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

🇧🇭 Regulatory and Research Services for Bahrain

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 Bahrain (GCC) market.

Our services comply with NHRA, MOH, GSO standards, GCC-DR, and WHO/ICH quality guidelines.

📘 Regulatory Services for Bahrain

🇧🇭 Regulatory & Product Registration Support – Bahrain

We support companies through every stage of Bahrain’s regulatory pathway, ensuring compliance with:

✔ NHRA – National Health Regulatory Authority
✔ MOH Bahrain – Drug & Supplement Regulatory Division
✔ GCC Drug Registration (GCC-DR) System
✔ GSO (Gulf Standards Organization)
✔ Bahrain Customs & Import Licensing Rules
✔ ICH Q/S/E Guidelines

📘 Product Registration Services

• Bahrain Dossier Preparation & Product Registration

– Preparation of dossiers in NHRA-CTD (similar to ICH-CTD)
– Registration of Pharmaceuticals (Rx/OTC) via national and GCC centralized procedure
– Food supplement & nutraceutical product registration with MOH Bahrain
– Herbal, natural, and traditional medicine registration
– Cosmetic product registration through NHRA Cosmetic Section
– Compliance with ingredient lists, restricted substances, GCC safety standards
– Complete regulatory documentation & local partner coordination

• Bahrain Label & Packaging Compliance

– Mandatory labeling in Arabic + English
– Compliance with GSO Labeling Standards
– Verification of health claims, warnings, allergens, expiry, batch details
– Packaging, IFU, and artwork development as per NHRA requirements

📗 Drug Master File (DMF) / API Submission – Bahrain

– DMF documentation compliant with NHRA + GCC guidelines
– ICH Q8/Q9/Q10 pharmaceutical quality data
– CEP/US DMF bridging for Bahrain submissions
– Manufacturer GMP evidence (EU/US/WHO GMP accepted)
– API stability & safety documentation for Bahrain import approval

⚗️ Bioequivalence (BE) Study Support – Bahrain

– BE study protocol design as per GCC & ICH guidelines
– Acceptance of BE studies from EU/US/India if accredited
– Complete BE report preparation for NHRA acceptance
– Biowaiver justification (BCS Class I/III APIs)

🔬 Analytical Method Validation (AMV) Services

– AMV according to ICH Q2(R2)
– Validation: assay, impurities, dissolution, RS, stability
– AMV protocol + raw data + final report
– Analytical method transfer support for Bahrain distributors/importers

🧾 Regulatory Consultancy & Compliance – Bahrain

– Product classification under NHRA (Medicine / Supplement / Cosmetic / Herbal)
– Importer/Local Agent (Bahrain-based) support
– GMP/GDP requirements for Bahrain registration
– Post-approval services: Variations, renewals, safety updates
– Pharmacovigilance (PV) support for MAH
– Regular monitoring of NHRA/GCC regulatory changes

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

💊 Formulation Development

– Tablets, capsules, syrups, liquids, injectables
– Stability studies for GCC climate (Hot & Humid Zone IVb)
– Formulation optimization for Bahrain’s regulatory expectations

🧫 Analytical R&D Services

– Method development & validation
– Impurity profiling, dissolution studies
– Real-time & accelerated stability testing for GCC markets

📑 Product Development Reports (PDRs)

– Preparation of PDR in CTD format
– Includes process development, analytical results & stability data

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial documents (protocols, CSR) per ICH-GCP (E6)
– Support for NHRA clinical trial submissions (Phase I–IV)
– Toxicology report preparation per OECD standards
– Cosmetic compliance:
✔ Ingredient assessment
✔ Safety evaluation reports
✔ GCC-compliant PIF documentation

🌏 Why Choose Us for the Bahrain Market

• Experts in NHRA, GCC regulatory systems, MOH Bahrain
• Complete technical & regulatory documentation support
• Fast & compliant CTD/DMF/AMV preparation
• Global experience in GCC, EU, US, ASEAN & ROW
• Strong support for pharmaceuticals, supplements, cosmetics & herbal products

📘 Regulatory & Dossier Documentation – Bahrain/GCC

Hashtags – Bahrain & GCC
#DossierBahrain #NHRA #GCCRegulatory #PharmaBahrain
#DMFBahrain #CTDBahrain #BahrainCosmetics #FoodSupplementBahrain
#HerbalProductBahrain #VeterinaryBahrain #PharmaComplianceGCC
#StabilityStudiesGCC #BMR #MFR #PSUR

⚗️ Bioequivalence & Analytical Services – Bahrain

#BEStudiesGCC #BioequivalenceBahrain #AMV #AssayValidation
#DissolutionValidation #GCCPharma

🧪 Technology Transfer & Safety – Bahrain

#TechnologyTransferGCC #MethodTransfer #MSDS
#PharmaTechTransferBahrain #AnalyticalTransfer