Regulatory And Research Services for Regulatory-Services-Coverage-by-South Africa-Market

🇿🇦 Regulatory and Research Services for South Africa

Dossier–DMF Services @ Zoesoe Exports Pvt Ltd

We, Zoesoe Exports Pvt Ltd, provide end-to-end regulatory and research services for pharmaceutical, nutraceutical, herbal, veterinary, food supplement, and cosmetic companies entering the South African market.

Our services fully comply with SAHPRA, NRCS, Department of Health, SAPC, SADC harmonized guidelines, and international WHO/ICH standards.

📘 Regulatory Services for South Africa

🇿🇦 Regulatory & Product Registration Support – South Africa

We assist companies with complete regulatory compliance under:

✔ SAHPRA – South African Health Products Regulatory Authority
✔ DoH – Department of Health (Medicines & Related Substances Act)
✔ SAPC – South African Pharmacy Council
✔ NRCS – Cosmetics, disinfectants & personal care regulation
✔ SADC Regulatory Harmonization (Southern Africa)
✔ WHO/ICH Q/S/E Guidelines

South Africa uses CTD-format dossiers for pharmaceuticals.

📘 Product Registration Services

• South Africa Dossier Preparation & Product Registration

– Pharmaceutical registration (Rx/OTC) with SAHPRA
– Complementary medicines registration (CM categories: herbal, Ayurveda, homeopathic, nutraceuticals)
– Health supplements & vitamins registration
– Cosmetic product notification with NRCS (aligned with EU Cosmetic Regulation 1223/2009)
– Medical devices registration (Class A–D)
– Veterinary product registration (Department of Agriculture – DAFF)
– Ingredient compliance according to SANS + SAHPRA lists
– End-to-end submission & follow-up until approval

• South Africa Label & Packaging Compliance

– Mandatory English labeling
– Compliance with SAHPRA + NRCS + SANS standards
– Verification of warnings, claims, dosage, expiry & storage
– Artwork, IFU & packaging creation per local laws

📗 Drug Master File (DMF) / API Documentation – South Africa

– DMF/ASMF preparation in CTD format for SAHPRA
– Bridging US DMF / CEP / EU ASMF
– GMP documentation (PIC/S GMP mandatory; South Africa is a PIC/S member)
– API stability, impurities & safety documentation
– API import permit support

⚗️ Bioequivalence (BE) Study Support – South Africa

– BE protocols based on SAHPRA + ICH guidelines
– Coordination with SAHPRA-approved CROs
– Foreign BE studies may be acceptable with justification
– Biowaiver support (BCS Class I/III)
– Complete BE report preparation

🔬 Analytical Method Validation (AMV) Services

– AMV as per ICH Q2(R2)
– Validation of assay, impurities, dissolution & stability methods
– Preparation of AMV protocols + raw data + validation reports
– QC method transfer for local labs

🧾 Regulatory Consultancy & Compliance – South Africa

– Classification: Medicine / Complementary Medicine / Supplement / Cosmetic / Device / Veterinary
– SAHPRA eCTD Portal submission support
– GMP, GDP & Pharmacovigilance compliance
– Variations, renewals & lifecycle maintenance
– Monitoring SAHPRA, NRCS, SADC & DoH regulatory updates

🧪 Research & Development (R&D) Services – South Africa Market

💊 Formulation Development

– Tablets, capsules, liquids, syrups, powders, injectables
– Stability studies aligned with Climate Zone II & IVb
– Reformulation for SAHPRA & NRCS compliance

🧫 Analytical R&D Services

– Assay, impurities, dissolution, stability
– Method development & validation
– Stability studies (accelerated + real-time)

📑 Product Development Reports (PDRs)

– Prepared in CTD/SAHPRA format
– Includes formulation, process, QC & stability data

🧍‍⚕️ Clinical Trial & Toxicology Support

– Clinical trial protocol & CSR development per ICH-GCP (E6)
– Support for SAHPRA clinical trial applications
– Toxicology evaluations per OECD
– Cosmetic safety assessments & PIF documentation
– Complementary medicine safety & efficacy documentation

🌏 Why Choose Us for the South African Market

• Strong experience with SAHPRA, NRCS, DoH & SAPC
• End-to-end regulatory, documentation & scientific services
• Fast & compliant CTD/DMF preparation for South Africa
• Deep experience in SADC markets: SA, Namibia, Botswana, Zimbabwe, Zambia
• Complete support for complementary medicines & supplements

📘 Regulatory & Dossier Documentation – South Africa

Hashtags – South Africa Market
#DossierSouthAfrica #SAHPRA #NRCS #PharmaSouthAfrica
#CosmeticsSouthAfrica #SupplementsSouthAfrica #HerbalSouthAfrica
#VeterinarySouthAfrica #CTDSouthAfrica #DMFSouthAfrica
#StabilityStudiesAfrica #BMR #MFR

⚗️ Bioequivalence & Analytical Studies – South Africa

#BEStudiesSouthAfrica #BioequivalenceSA #AMV
#DissolutionValidation #AssayValidation

🧪 Technology Transfer & Safety – South Africa

#TechnologyTransferSA #MethodTransfer #MSDS
#PharmaTechTransferSouthAfrica