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

🇧🇷 Regulatory and Research Services for Brazil

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

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

Our services comply with ANVISA, Ministry of Health, MAPA, INMETRO, and global ICH/WHO standards.

📘 Regulatory Services for Brazil

🇧🇷 Regulatory & Product Registration Support – Brazil

We support companies at every step of product authorization according to:

✔ ANVISA – Brazilian Health Regulatory Authority
✔ RDC Guidelines (Resoluções da Diretoria Colegiada)
✔ MAPA – Ministry of Agriculture (for veterinary & animal products)
✔ INMETRO – Cosmetics, devices & packaging standards
✔ Brazil CTD (Módulos 1–5) requirements
✔ WHO/ICH Q/S/E Guidelines

Brazil follows a unique CTD structure requiring local dossiers, legalized documents & safety data.

📘 Product Registration Services

• Brazil Dossier Preparation & Registration

– Pharmaceutical product registration (Rx/OTC) under ANVISA
– Generic, Similar, Innovative & Biological drug submissions
– Food supplement & nutraceutical notification (RDC 243/2018)
– Herbal & Traditional Phytomedicine registration
– Cosmetic product registration/notification (RDC 07/2015, Grade 1 & Grade 2 cosmetics)
– Veterinary product registration with MAPA
– Ingredient compliance based on ANVISA + INMETRO approved lists
– GMP certification coordination (mandatory for imported drugs)

• Brazil Label & Packaging Compliance

– Mandatory Portuguese labeling
– Compliance with ANVISA RDC labeling standards
– Verification of claims, warning statements, dosage, batch, expiry
– Packaging & IFU development according to Brazil regulations

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

– DMF/DIFA preparation in Brazilian CTD format (Módulo 3)
– Support for CEP/ASMF/US DMF bridging where acceptable
– GMP documentation (ANVISA GMP Certification required for APIs and finished products)
– API impurity, stability & quality documentation
– Assistance with ANVISA Certificação de Boas Práticas de Fabricação (CBPF)

⚗️ Bioequivalence (BE) Study Support – Brazil

– BE study protocols per ANVISA RDC 166/2017 & ICH
– Coordination with Brazil-accredited CROs
– Acceptance of foreign BE studies only with strict ANVISA justification
– Biowaiver support for BCS Class I APIs
– Complete BE study report preparation for ANVISA submission

🔬 Analytical Method Validation (AMV) Services

– AMV as per ANVISA RDC 166/2017 + ICH Q2(R2)
– Validation of assay, impurities, dissolution, stability
– AMV protocol + chromatograms + statistical evaluation
– Method transfer documentation for Brazilian QC labs

🧾 Regulatory Consultancy & Compliance – Brazil

– Product classification: Drug / Generic / Similar / Phytomedicine / Supplement / Cosmetic / Veterinary
– ANVISA e-submission (Peticionamento Eletrônico) support
– GMP, GDP & pharmacovigilance compliance guidance
– Post-approval: variations, renewals, PSURs (RMM), labeling changes
– Monitoring of ANVISA RDC updates

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

💊 Formulation Development

– Tablets, capsules, liquids, injectables, powders
– Stability testing for tropical climate Zone IVb
– Reformulation to comply with ANVISA impurity & excipient rules

🧫 Analytical R&D Services

– Assay, impurities, dissolution, stability studies
– QC method development & validation
– Real-time & accelerated stability per ICH & ANVISA

📑 Product Development Reports (PDRs)

– PDR prepared in Brazil CTD format (Módulos 2 & 3)
– Includes process, analytical, safety & stability summaries

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial documents per ICH-GCP (E6)
– Support for ANVISA clinical trial authorization (DCA submission)
– Toxicology evaluation as per OECD & ANVISA requirements
– Cosmetic safety & toxicological risk assessments (RDC 07/2015)

🌏 Why Choose Us for the Brazil Market

• Strong experience with ANVISA GMP, Dossier, and Regulatory Filings
• Expertise across pharmaceuticals, cosmetics, supplements & herbal products
• Full support: classification → documentation → ANVISA submission → approval
• Experience with Latin America, EU, US, GCC, Africa & ASEAN
• Fast CTD/DMF/AMV preparation tailored to Brazilian regulatory rules

📘 Regulatory & Dossier Documentation – Brazil

Hashtags – Brazil Market
#DossierBrazil #ANVISA #BrazilPharma
#BrazilCosmetics #BrazilSupplements #BrazilHerbal
#PharmaBrazil #DMFBrazil #CTDBrazil #StabilityStudies
#BMR #MFR #ANVISAGMP #RDC166 #RDC243

⚗️ Bioequivalence & Analytical Studies – Brazil

#BEStudiesBrazil #BioequivalenceBrazil #AMV
#AssayValidation #DissolutionValidation

🧪 Technology Transfer & Safety – Brazil

#TechnologyTransferBrazil #MethodTransfer #MSDS
#PharmaTechTransferBrazil