🇦🇫 Analytical Method Validation Services – Afghanistan

Ensuring Quality and Compliance for Submissions to the National Medicines and Health Products Regulatory Authority (NMHRA)

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 compliance with Afghanistan's regulatory requirements.

We support pharmaceutical manufacturers and suppliers seeking registration and import permits in Afghanistan, aligning documentation with the expectations of the National Medicines and Health Products Regulatory Authority (NMHRA), referencing internationally accepted standards (WHO/ICH) to ensure quality and safety.

🇦🇫 Our Core Expertise – Afghanistan Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation required by the NMHRA. Afghanistan's regulatory body generally accepts methods and quality standards based on internationally recognized pharmacopoeias and WHO guidelines.

• ✅ Assay Method Validation

  • Potency and content determination

  • Validation strictly as per ICH Q2 (R1 / R2) aligned with global best practices and NMHRA expectations.

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

  • USP/EP/BP harmonized methods.

• ✅ Impurities Method Validation

  • Related substances & degradation product profiling.

  • Identification and quantification of impurities.

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

• ✅ Dissolution Method Validation

  • Immediate & modified release products.

  • Discriminatory dissolution method development.

  • Compliance with drug registration requirements, generally submitted in a comprehensive dossier format.

• ✅ Residual Solvents Method Validation

  • Gas Chromatographic (GC) method validation.

  • Compliance with ICH Q3C (internationally accepted standard).

  • Class I, II & III residual solvents.

  • Limits, system suitability, accuracy, and precision.

🇦🇫 Products Covered – Afghanistan

• ✅ Active Pharmaceutical Ingredients (APIs)

• ✅ Essential medicines and pharmaceutical finished products

• ✅ Oral solid dosage forms (tablets, capsules)

• ✅ Injectable formulations (sterile & non-sterile)

• ✅ Semi-solid & liquid dosage forms

🇦🇫 Regulatory Compliance – Afghanistan

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2) and other relevant ICH guidelines (often used as the primary scientific standard).

• WHO Guidelines for Quality Assurance of Pharmaceuticals and drug registration.

• NMHRA (National Medicines and Health Products Regulatory Authority) requirements for imported medicines.

• United States Pharmacopeia (USP), European Pharmacopoeia (EP), and British Pharmacopoeia (BP) (primary quality references).

• Good Manufacturing Practices (GMP) recognized by the NMHRA (e.g., WHO-GMP).

🇦🇫 Post-Submission Regulatory Support (Afghanistan)

VALIDEX provides support for technical documentation required by the NMHRA for drug registration and importation, assisting with:

• ✅ Response to NMHRA deficiency letters or technical queries.

• ✅ Scientific justification for validation parameters and analytical methods.

• ✅ Data gap assessment & corrective documentation.

• ✅ Provision of high-quality validation protocols and reports acceptable for international dossiers.

🇦🇫 Why Choose VALIDEX for Afghanistan?

• ✔ Documentation prepared to international standards (ICH/WHO) that simplify review and acceptance by the NMHRA.

• ✔ Focus on WHO/PIC/S compliance, crucial for demonstrating quality in the region.

• ✔ 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 – Afghanistan

• Analytical Method Validation Protocols (Internationally Aligned).

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• Technical summaries suitable for NMHRA dossier requirements.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇦🇫 Industries We Serve in Afghanistan

• International pharmaceutical manufacturers exporting to Afghanistan.

• Local importers and distributors of medicines.

• Regulatory & dossier consulting firms serving the market.

🇦🇫 National & Export Support

VALIDEX supports Analytical Method Validation for:

• Afghanistan domestic approvals (Drug Registration/Importation from NMHRA).

• Export dossiers for manufacturers supplying Afghanistan.

🇦🇫 Partner with VALIDEX – Afghanistan

Achieve NMHRA-ready analytical validation with confidence.

From method validation to documentation, VALIDEX is your trusted scientific and regulatory partner in Afghanistan.