🇧🇳 Analytical Method Validation Services – Brunei Darussalam

Ensuring Quality, Compliance, and Regulatory Confidence for Submissions to the MoH Pharmacy Services

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 Sultanate of Brunei Darussalam's regulatory requirements.

We support pharmaceutical manufacturers and suppliers seeking registration and importation in Brunei, aligning documentation with the expectations of the Ministry of Health (MoH) Pharmacy Services and international standards such as ICH and WHO.

🇧🇳 Our Core Expertise – Brunei Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Brunei MoH Pharmacy Services. Brunei generally accepts methods and standards based on recognized international references (e.g., UK, Australia, Singapore) and global guidelines.

• ✅ Assay Method Validation (Pengesahan Kaedah Asai)

  • Potency and content determination

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

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

  • BP/Ph. Eur./USP harmonized methods.

• ✅ Impurities Method Validation (Pengesahan Kaedah Kekotoran)

  • Related substances & degradation product profiling.

  • Identification and quantification of impurities.

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

• ✅ Dissolution Method Validation (Pengesahan Kaedah Pembubaran)

  • Immediate & modified release products.

  • Discriminatory dissolution method development.

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

  • Compliance with drug registration requirements.

• ✅ Residual Solvents Method Validation (Pengesahan Kaedah Pelarut Baki)

  • 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 – Brunei Darussalam

• ✅ Active Pharmaceutical Ingredients (APIs)

• ✅ Oral solid dosage forms (tablets, capsules)

• ✅ Injectable formulations (sterile & non-sterile)

• ✅ Semi-solid & liquid dosage forms

• ✅ Traditional/Herbal Medicines (where applicable, with quality testing).

🇧🇳 Regulatory Compliance – Brunei Darussalam

All Analytical Method Validation activities are conducted in accordance with:

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

• Brunei MoH Pharmacy Services regulations and guidelines.

• British Pharmacopoeia (BP) and European Pharmacopoeia (Ph. Eur.) (key reference standards).

• Good Manufacturing Practices (GMP) recognized by the MoH (e.g., PIC/S, UK MHRA).

🇧🇳 Post-Submission Regulatory Support (Brunei)

VALIDEX provides support for technical documentation required by the MoH Pharmacy Services for product registration and import, assisting with:

• ✅ Response to technical queries or deficiency letters from the MoH.

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Provision of high-quality validation protocols and reports acceptable for the market.

🇧🇳 Why Choose VALIDEX for Brunei?

• ✔ Strong understanding of the Brunei MoH's quality and safety expectations, referencing international standards.

• ✔ ICH-aligned documentation focused on ASEAN/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 – Brunei Darussalam

• Analytical Method Validation Protocols (MoH-compliant).

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• Technical summaries suitable for MoH dossier submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇧🇳 Industries We Serve in Brunei

• International pharmaceutical manufacturers exporting to Brunei.

• Local importers and distributors of medicines.

• Regulatory & dossier consulting firms serving the market.

🇧🇳 National & Export Support

VALIDEX supports Analytical Method Validation for:

• Brunei domestic approvals (Product Registration from the MoH).

• Manufacturing licenses & product permissions.

• Export dossiers globally.

🇧🇳 Partner with VALIDEX – Brunei Darussalam

Achieve MoH-ready analytical validation with confidence.

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