Analytical Method Validation Services – Indonesia

Ensuring Accuracy. Compliance. Regulatory Confidence for Indonesia Regulatory Submissions

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, fully compliant with Indonesian regulatory requirements.

We support pharmaceutical manufacturers and exporters targeting Indonesia with BPOM-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of National Agency of Drug and Food Control (BPOM) queries for product registration, import authorization, and export dossiers.

Our Core Expertise – Indonesia Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation, as required by the National Agency of Drug and Food Control (BPOM – Badan POM), Republic of Indonesia.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by BPOM Indonesia
• Accuracy, precision, linearity, robustness, and specificity
• Harmonized analytical methods as per USP / BP / EP / IP

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of process- and degradation-related impurities
• Stability-indicating method validation aligned with BPOM and ICH expectations

✅ Dissolution Method Validation

• Immediate-release and modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition assessment, and robustness studies
• Compliance with BPOM product registration requirements

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C accepted by BPOM Indonesia
• Class I, II, and III residual solvents
• Limit justification, system suitability, accuracy, and precision

Products Covered – Indonesia

✅ Active Pharmaceutical Ingredients (APIs)
✅ Oral solid dosage forms (tablets, capsules, powders, sachets)
✅ Injectable formulations (sterile and non-sterile)
✅ Semi-solid and liquid dosage forms
✅ Modified-release and controlled-release products

Regulatory Compliance – Indonesia

All Analytical Method Validation activities are conducted in accordance with:

• National Agency of Drug and Food Control (BPOM) guidelines
• Indonesian National Drug Registration Regulations
• ICH Q2 (R1 / R2)
• ICH Q3C for residual solvents
• WHO-GMP / PIC/S GMP principles adopted by BPOM
• Recognized pharmacopoeias (USP, BP, EP, IP)

Post-Submission Regulatory Support – Indonesia

VALIDEX provides complete BPOM query management, including:

✅ Responses to BPOM deficiency letters and review comments
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and validation reports
✅ Technical support during BPOM inspections, audits, and dossier evaluations

Why Choose VALIDEX for Indonesia?

✔ Strong understanding of BPOM regulatory expectations
✔ ICH-aligned, Indonesia-focused documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Efficient timelines for Indonesia registration projects
✔ Strict confidentiality and data integrity compliance
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Indonesia

• Analytical Method Validation Protocols (Indonesia-compliant)
• Validation Reports for:
– Assay
– Impurities
– Dissolution
– Residual Solvents
• Dossier summaries for BPOM submissions
• Regulatory query response packages
• Method transfer, verification, and analytical bridging documentation

Industries We Serve – Indonesia

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic formulation companies
• Contract Manufacturing Organizations (CMOs)
• Importers and Marketing Authorization Holders (MAHs)
• Regulatory and dossier consulting firms

National & Export Support – Indonesia

VALIDEX supports Analytical Method Validation for:

• Indonesia domestic product registration (BPOM)
• Import licensing and marketing authorization
• Export dossiers prepared for submission to Indonesia
• Government supply and international tender registrations

Partner with VALIDEX – Indonesia

Achieve BPOM-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Indonesia.