🇲🇦 Analytical Method Validation Services – Morocco

Assurer l'Exactitude. La Conformité. La Confiance Réglementaire pour les Soumissions Réglementaires au Maroc

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 Morocco's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Morocco with compliance aligned with the Direction du Médicament et de la Pharmacie (DMP), ICH-aligned documentation, and post-submission handling of DMP queries for drug registration (AMM - Autorisation de Mise sur le Marché), licensing, and import/export requirements.

🇲🇦 Our Core Expertise – Morocco Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Directorate of Medicines and Pharmacy (DMP) and internationally accepted pharmacopoeial standards, often following guidelines from the WHO and regional Maghreb standards.

• ✅ Assay Method Validation (Validation de la Méthode de Dosage)

  • Potency and content determination

  • Validation as per ICH Q2 (R1 / R2) aligned with DMP and European/regional quality expectations

  • Accuracy, precision, linearity, robustness, and specificity

  • EP/USP/BP harmonized methods

• ✅ Impurities Method Validation (Validation de la Méthode des Impuretés)

  • Related substances & degradation product profiling

  • Identification and quantification of impurities

  • Stability-indicating method validation as per ICH and WHO-GMP

• ✅ Dissolution Method Validation (Validation de la Méthode de Dissolution)

  • Immediate & modified release products

  • Discriminatory dissolution method development

  • Media selection, sink condition assessment, and method robustness

  • Compliance with product registration requirements, following international norms (CTD format).

• ✅ Residual Solvents Method Validation (Validation de la Méthode des Solvants Résiduels)

  • Gas Chromatographic (GC) method validation

  • Compliance with ICH Q3C adopted globally, aligning with DMP's quality expectations

  • Class I, II & III residual solvents

  • Limits, system suitability, accuracy, and precision

🇲🇦 Products Covered – Morocco

• ✅ 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 – Morocco

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)

• DMP Guidelines and national pharmaceutical legislation (Loi 17-04 related to the code of medicines and pharmacy)

• WHO-GMP recommendations, widely accepted in the region

• European Pharmacopoeia (EP) (often prioritized)

• United States Pharmacopeia (USP)

• British Pharmacopoeia (BP)

🇲🇦 Post-Submission Regulatory Support (Morocco)

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

• ✅ Response to regulatory deficiency letters

• ✅ 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 Morocco?

• ✔ Strong understanding of Morocco's DMP regulatory expectations and regional standards

• ✔ ICH-aligned documentation focused on European and Maghreb 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 – Morocco

• Analytical Method Validation Protocols (DMP-compliant)

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD / Non-CTD summary documents for DMP submissions (Dossiers must be in French)

• Regulatory query response packages

• Method transfer & verification documentation

🇲🇦 Industries We Serve in Morocco

• 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:

• Morocco domestic approvals (AMM from DMP)

• Manufacturing licenses & product permissions

• Export dossiers for regional and international shipment from Morocco

🇲🇦 Partner with VALIDEX – Morocco

Achieve DMP-ready analytical validation with confidence.

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