🇿🇦 Analytical Method Validation Services – South Africa

Ensuring Accuracy. Compliance. Regulatory Confidence for South African Regulatory Submissions

VALIDEX, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end Analytical Method Validation (AMV) services for Active Pharmaceutical Ingredients (APIs) and Pharmaceutical Finished Products in full compliance with South Africa's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across South Africa with compliance aligned with the South African Health Products Regulatory Authority (SAHPRA), ICH-aligned documentation, and post-submission handling of SAHPRA queries for medicine registration, licensing, and import/export requirements.

🇿🇦 Our Core Expertise – South Africa Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by SAHPRA and internationally accepted pharmacopoeial standards. South Africa is an ICH Observer, making alignment with these guidelines paramount.

• ✅ Assay Method Validation

  • Potency and content determination

  • Validation strictly as per ICH Q2 (R1 / R2) aligned with SAHPRA expectations

  • Accuracy, precision, linearity, range, robustness, and specificity

  • BP/USP/EP harmonized methods

• ✅ Impurities Method Validation

  • Related substances & degradation product profiling

  • Identification and quantification of impurities

  • Stability-indicating method validation as per ICH Q3 and SAHPRA guidelines

• ✅ Dissolution Method Validation

  • Immediate & modified release products

  • Discriminatory dissolution method development

  • Media selection, sink condition assessment, and method robustness

  • Compliance with SAHPRA product registration requirements (CTD format).

• ✅ Residual Solvents Method Validation

  • Gas Chromatographic (GC) method validation

  • Compliance with ICH Q3C adopted by SAHPRA

  • Class I, II & III residual solvents

  • Limits, system suitability, accuracy, and precision

🇿🇦 Products Covered – South Africa

• ✅ Active Pharmaceutical Ingredients (APIs)

• ✅ Oral solid dosage forms (tablets, capsules, sachets)

• ✅ Injectable formulations (sterile & non-sterile)

• ✅ Semi-solid & liquid dosage forms

• ✅ Modified & controlled release products

🇿🇦 Regulatory Compliance – South Africa

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2) and other relevant ICH guidelines (Q1, Q3, Q7)

• SAHPRA Guidelines and the Medicines and Related Substances Act, No. 101 of 1965

• WHO-GMP and PIC/S standards, widely endorsed by SAHPRA

• British Pharmacopoeia (BP)

• United States Pharmacopeia (USP)

• European Pharmacopoeia (EP)

🇿🇦 Post-Submission Regulatory Support (South Africa)

VALIDEX provides complete regulatory query management, assisting with responses to SAHPRA and other competent authorities, including:

• ✅ Response to SAHPRA deficiency letters (often related to CMC data)

• ✅ Scientific justification for validation parameters

• ✅ Data gap assessment & corrective documentation

• ✅ Revised validation protocols and reports

• ✅ Technical support during regulatory inspections & audits

🇿🇦 Why Choose VALIDEX for South Africa?

• ✔ Strong understanding of SAHPRA's rigorous regulatory expectations and CTD requirements

• ✔ ICH-aligned documentation focused on African and international compliance norms

• ✔ Inspection-ready and audit-compliant validation reports

• ✔ Fast turnaround timelines

• ✔ Strict confidentiality & data integrity

• ✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

🇿🇦 Our Deliverables – South Africa

• Analytical Method Validation Protocols (SAHPRA-compliant)

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 summary documents for SAHPRA submissions

• Regulatory query response packages

• Method transfer & verification documentation

🇿🇦 Industries We Serve in South Africa

• Pharmaceutical manufacturing companies

• API traders and importers

• Generic formulation companies

• Contract Manufacturing Organizations (CMOs)

• Import and Distribution companies

• Regulatory & dossier consulting firms

🇿🇦 National & Export Support

VALIDEX supports Analytical Method Validation for:

• South Africa domestic approvals (Market Authorization from SAHPRA)

• Manufacturing licenses & product permissions

• Export dossiers for regional (SADC) and international shipment from South Africa

🇿🇦 Partner with VALIDEX – South Africa

Achieve SAHPRA-ready analytical validation with confidence.

From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner in South Africa.