Analytical Method Validation Services – Turkey

Ensuring Accuracy. Compliance. Regulatory Confidence for Turkey 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 Turkish regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Turkey with TİTCK-compliant analytical validation, ICH- and EU-aligned documentation, and complete post-submission handling of TİTCK queries for product registration, marketing authorization, manufacturing/import licensing, and export dossiers.

Our Core Expertise – Turkey Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Turkish Medicines and Medical Devices Agency (TİTCK) under the Ministry of Health, Republic of Türkiye.

✅ Assay Method Validation

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

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of impurities
• Stability-indicating method validation aligned with TİTCK, ICH, and EU expectations
• Compliance with ICH Q3A / Q3B and European Pharmacopoeia (Ph. Eur.) limits

✅ Dissolution Method Validation

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

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C adopted by TİTCK
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, and precision

Products Covered – Turkey

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

Regulatory Compliance – Turkey

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• TİTCK Drug Registration Guidelines
• Regulation on Licensing of Medicinal Products for Human Use
• EU-aligned Turkish Pharmaceutical Legislation
• European Pharmacopoeia (Ph. Eur.)
• WHO-GMP & EU-GMP Guidelines (recognized by TİTCK)
• USP / BP Pharmacopoeial Standards (where applicable)

Post-Submission Regulatory Support – Turkey

VALIDEX provides complete TİTCK query management, including:

✅ Responses to TİTCK deficiency letters and scientific evaluation queries
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during TİTCK inspections, audits, and dossier evaluations

Why Choose VALIDEX for Turkey?

✔ Strong understanding of TİTCK & EU-aligned regulatory expectations
✔ ICH- and Ph. Eur.-aligned documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Fast turnaround timelines
✔ Strict confidentiality and data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Turkey

• Analytical Method Validation Protocols (TİTCK-compliant)
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD / eCTD Module 3 summaries for TİTCK submissions
• Regulatory query response packages
• Method transfer, verification, and re-validation documentation

Industries We Serve in Turkey

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic and branded formulation companies
• Contract Manufacturing Organizations (CMOs)
• Marketing Authorization Holders (MAHs)
• Importers, distributors, and regulatory consulting firms

National & Export Support – Turkey

VALIDEX supports Analytical Method Validation for:

• Turkey domestic product registration (TİTCK)
• Manufacturing and import license applications
• Export dossiers prepared for Turkey, EU-referenced, and international markets

Partner with VALIDEX – Turkey

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