🇿🇦 Analytical Method Validation Services – Africa

Global Analytical Method Validation Services for African Regulatory Markets

Accuracy. Compliance. Regulatory Confidence.

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 for African regulatory markets.

We support pharmaceutical manufacturers supplying medicines to African Ministries of Health (MOH) with ICH-compliant analytical validation, regulatory documentation, and post-submission query handling aligned with African regulatory expectations.

Our Core Expertise

VALIDEX offers complete preparation, review, and regulatory support for Analytical Method Validation, covering:

✅ Assay Method Validation

• Potency and content determination
• Protocol development compliant with ICH Q2
• Evaluation of critical validation parameters:

• Accuracy

• Precision

• Linearity

• Robustness

• Specificity

✅ Impurities Method Validation

• Related substances analysis
• Identification & quantification of impurities
• Stability-indicating analytical methods
• Forced degradation study support

✅ Dissolution Method Validation

• Immediate release dosage forms
• Modified & controlled release products
• Discriminatory dissolution method development
• Dissolution media selection and sink condition evaluation

✅ Residual Solvents Method Validation

• GC method validation as per ICH Q3C

Validation scope includes:

• Class I solvents
• Class II solvents
• Class III solvents

Evaluation includes:

• Limit testing
• System suitability
• Detection & quantification limits

Products Covered

VALIDEX supports validation for a wide range of pharmaceutical products supplied to African markets:

✅ Active Pharmaceutical Ingredients (APIs)
✅ Oral solid dosage forms (tablets & capsules)
✅ Injectable formulations
✅ Semi-solid formulations (creams, gels, ointments)
✅ Liquid formulations (oral & topical)
✅ Modified & controlled release products

Regulatory Compliance for Africa

All validation work is performed in alignment with international and African regulatory expectations, including:

• ICH Q2
• World Health Organization pharmaceutical guidelines
• African Medicines Agency regulatory harmonization initiatives
• National MOH regulatory requirements across African countries

Pharmacopoeial standards used:

• United States Pharmacopeia

• European Pharmacopoeia

• British Pharmacopoeia

• Indian Pharmacopoeia

Post-Submission Regulatory Support

VALIDEX provides complete support for African regulatory queries, including:

✅ MOH deficiency response preparation
✅ Scientific justification and data gap analysis
✅ Revised validation reports and additional validation data
✅ Technical responses during regulatory inspections
✅ Support for WHO-based reliance and regulatory review pathways

Why Choose VALIDEX?

✔ Strong scientific and regulatory expertise
✔ Experience with African regulatory submissions
✔ Authority-ready validation documentation
✔ Fast turnaround timelines
✔ Strict confidentiality and data integrity
✔ One-point solution under Zoesoe Exports Pvt Ltd

Our Deliverables

• Analytical Method Validation Protocols
• Validation Reports (Assay, Impurities, Dissolution, Residual Solvents)
• Summary validation reports for dossier submissions
• Regulatory response documentation
• Method transfer and verification reports

Industries We Serve

• Pharmaceutical manufacturers
• Generic drug companies
• Contract manufacturing organizations (CMOs)
• Export-oriented pharmaceutical companies
• Regulatory dossier consultants

Africa Market Coverage

VALIDEX supports Analytical Method Validation projects for pharmaceutical submissions across African regulatory markets, including:

🇰🇪 Kenya
🇳🇬 Nigeria
🇪🇹 Ethiopia
🇹🇿 Tanzania
🇺🇬 Uganda
🇬🇭 Ghana
🇿🇦 South Africa
🇿🇲 Zambia
🇧🇼 Botswana
🌍 Other African MOH jurisdictions

Partner with VALIDEX

Achieve regulatory-ready analytical validation for African pharmaceutical markets with confidence.

From method validation to regulatory approvals, VALIDEX is your trusted scientific partner for Africa-focused pharmaceutical submissions.