🇧🇭 Analytical Method Validation Services – Kingdom of Bahrain

Ensuring Accuracy, Compliance, and Regulatory Confidence for Submissions to the NHRA

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 the Kingdom of Bahrain's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Bahrain with compliance aligned with the National Health Regulatory Authority (NHRA), ICH-aligned documentation, and post-submission handling of NHRA queries for drug registration, licensing, and import/export requirements.

🇧🇭 Our Core Expertise – Bahrain Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Bahrain NHRA. The NHRA generally accepts methods and standards based on the US, EU, and ICH guidelines, using the CTD format for submissions.

• ✅ Assay Method Validation (تحقق طريقة المعايرة)

  • Potency and content determination

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

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

  • USP/EP/BP harmonized methods.

• ✅ Impurities Method Validation (تحقق طريقة الشوائب)

  • Related substances & degradation product profiling.

  • Identification and quantification of impurities.

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

• ✅ Dissolution Method Validation (تحقق طريقة الذوبان)

  • Immediate & modified release products.

  • Discriminatory dissolution method development.

  • Media selection, sink condition assessment, and method robustness.

  • Compliance with drug registration requirements, submitted in CTD format.

• ✅ Residual Solvents Method Validation (تحقق طريقة المذيبات المتبقية)

  • Gas Chromatographic (GC) method validation.

  • Compliance with ICH Q3C (adopted by NHRA).

  • Class I, II & III residual solvents.

  • Limits, system suitability, accuracy, and precision.

🇧🇭 Products Covered – Bahrain

• ✅ Active Pharmaceutical Ingredients (APIs)

• ✅ Oral solid dosage forms (tablets, capsules)

• ✅ Injectable formulations (sterile & non-sterile)

• ✅ Semi-solid & liquid dosage forms

• ✅ Modified & controlled release products

🇧🇭 Regulatory Compliance – Bahrain

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2) and other relevant ICH guidelines.

• NHRA (National Health Regulatory Authority) Drug Registration Requirements and Circulars.

• United States Pharmacopeia (USP) and European Pharmacopoeia (EP) (primary references).

• Good Manufacturing Practices (GMP) recognized by Bahrain (e.g., PIC/S or WHO).

🇧🇭 Post-Submission Regulatory Support (Bahrain)

VALIDEX provides complete regulatory query management, assisting with responses to NHRA queries and technical review requirements, including:

• ✅ Response to NHRA deficiency letters.

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

• ✅ Technical support during NHRA inspections & audits.

🇧🇭 Why Choose VALIDEX for Bahrain?

• ✔ Strong understanding of the NHRA's rigorous regulatory expectations and preference for international (US/EU) standards.

• ✔ ICH-aligned documentation focused on Bahraini national compliance norms and alignment with GCC expectations.

• ✔ 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 – Bahrain

• Analytical Method Validation Protocols (NHRA-compliant).

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for NHRA submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇧🇭 Industries We Serve in Bahrain

• Pharmaceutical manufacturing companies.

• API manufacturers 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:

• Bahrain domestic approvals (Drug Registration from NHRA).

• Manufacturing licenses & product permissions.

• Export dossiers globally (including GCC).

🇧🇭 Partner with VALIDEX – Bahrain

Achieve NHRA-ready analytical validation with confidence.

From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner in the Kingdom of Bahrain.