Regulatory And Research Services for Regulatory-Services-Coverage-by-United Kingdom-Market
🇬🇧 Regulatory and Research Services for the United Kingdom
Dossier–DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, provide comprehensive regulatory and research solutions for pharmaceutical, nutraceutical, herbal, food supplement, cosmetic, and veterinary companies aiming to enter the United Kingdom market.
Our services ensure full compliance with MHRA, UK FSA, OPSS, UK Cosmetic Regulation, and ICH/WHO standards.
📘 Regulatory Services for the United Kingdom
🇬🇧 Regulatory & Product Registration Support – UK
We support companies through the full regulatory pathway for entering the UK market, ensuring compliance with:
✔ MHRA – Medicines and Healthcare products Regulatory Agency
✔ FSA – Food Standards Agency
✔ OPSS – Office for Product Safety and Standards
✔ UK-specific post-Brexit regulations
✔ ICH Q/S/E Guidelines
📘 Product Registration Services
• UK Dossier Preparation & Market Authorization
– MHRA CTD submission for pharmaceuticals (Rx/OTC) in the UK format
– UK food supplement compliance (FSA)
– Cosmetic product notification via UK SCPN (UK Submit Cosmetic Product Notification)
– Support for Herbal, Ayurveda, Nutraceutical, Veterinary product classification
– Ingredient & claim compliance based on:
✔ UK Retained EU Law (Health & Nutrition Claims)
✔ UK Novel Foods Regulation
✔ UK Cosmetics Regulation (adapted from EC 1223/2009)
• UK Label & Packaging Compliance
– English-language label review (mandatory)
– Compliance with UK Food Information Regulations 2014
– Verification of warnings, allergy information, nutrition declarations
– IFU/leaflet and packaging layout development
📗 Drug Master File (DMF) / ASMF Services
– Preparation of MHRA-compliant ASMF/DMF
– EU-to-UK DMF adaptation post-Brexit
– Technical documentation for APIs following MHRA, ICH & UK GMP
– CEP (EDQM) alignment and bridging for UK submissions
⚗️ Bioequivalence (BE) Study Support – UK
– BE study design based on MHRA/EMA Hybrid Guidelines
– Coordination with UK/EU-accredited CROs
– Preparation of full BE study reports for UK submissions
– Biowaiver support based on BCS classification
🔬 Analytical Method Validation (AMV) Services
– Validation as per ICH Q2(R2)
– Method development for assay, impurity, dissolution & stability
– AMV documentation tailored for MHRA submissions
– QC support for product release testing
🧾 Regulatory Consultancy & Compliance – UK
– UK regulatory pathway assessment (Drug / Food Supplement / Cosmetic)
– UK Responsible Person (RP) guidance for cosmetics
– Importer/Distributor obligations under UK law
– Post-approval maintenance:
✔ Variations
✔ Renewals
✔ PSURs
✔ Pharmacovigilance support
– Continuous monitoring of MHRA & FSA updates
🧪 Research & Development (R&D) Services – UK Market
💊 Formulation Development
– Tablets, capsules, liquids, syrups, powders, injectables
– UK climate stability studies (Zone II equivalent)
– Optimization for efficacy & UK consumer preferences
🧫 Analytical R&D Services
– Assay, dissolution, impurity profiling
– Method development & validation
– Stability studies (real-time & accelerated)
📑 Product Development Reports (PDRs)
– UK-adapted CTD-style PDRs
– Includes analytical data, process development & stability summary
🧍⚕️ Clinical Trial & Toxicology Support – UK
– Clinical trial protocol preparation as per MHRA GCP & ICH-GCP
– Toxicology studies following OECD guidelines
– Cosmetic compliance documentation:
✔ PIF – Product Information File
✔ CPSR – Cosmetic Product Safety Report
✔ UK Responsible Person (RP) support
🌏 Why Choose Us for the UK Market
• Specialists in MHRA & UK post-Brexit regulations
• End-to-end regulatory & technical documentation support
• Experience across EU, US, ASEAN & ROW
• High-quality CTD/ASMF submissions with fast turnaround
• Tailored regulatory strategies for UK-specific requirements
📘 Regulatory & Dossier Documentation – UK
Hashtags – United Kingdom
#DossierUK #DMFUK #CTDUK #MHRA #UKRegulatory
#PharmaUK #PharmaComplianceUK #PharmaQualityUK
#FSAUK #OPSSUK #PSUR #StabilityStudiesUK
#ClinicalTrialReportUK #ProcessValidationUK #BMR #MFR
⚗️ Bioequivalence & Analytical Studies – UK
#BEStudiesUK #BioequivalenceStudyUK #AnalyticalMethodValidationUK
#AMVUK #DissolutionValidationUK #AssayValidationUK
🧪 Technology Transfer & Safety – UK
#TechnologyTransferUK #AnalyticalTransferUK #MethodTransferUK
#MSDSUK #PharmaTechTransferUK
🌐 Top Pharma & Regulatory Hashtags – UK
#PharmaUK #MHRA #UKCA #SCPNUK #UKCosmeticRegulation
#PharmaManufacturingUK #PharmaQualityUK #TechTransferUK
#ClinicalTrialReportUK #StabilityStudiesUK