Analytical Method Validation Services – Cyprus (EU)

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 Cyprus and European Union regulatory requirements.

We support pharmaceutical manufacturers, API producers, Marketing Authorization Holders (MAHs), CMOs, and export-oriented companies targeting Cyprus and the EU market with Cyprus MoH / Pharmaceutical Services–compliant analytical validation, EMA-aligned documentation, and complete post-submission handling of regulatory queries for national, decentralized (DCP), mutual recognition (MRP), and centralized EU procedures.

Our Core Expertise – Cyprus / EU Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Pharmaceutical Services, Ministry of Health (Cyprus) and aligned with EMA, ICH, and European Pharmacopoeia (Ph. Eur.) requirements.

✅ Assay Method Validation

• Potency and content determination for APIs & finished products
• Validation in accordance with ICH Q2 (R1 / R2) adopted by the EU
• Accuracy, precision, linearity, range, robustness, and specificity
• Ph. Eur. / USP / BP harmonized analytical methods

✅ Impurities Method Validation

• Related substances, degradation products, and process impurities
• Identification, qualification, and quantification of impurities
• Stability-indicating method validation as per Ph. Eur. & EMA guidelines
• Compliance with ICH Q3A / Q3B / Q3C / Q3D

✅ Dissolution Method Validation

• Immediate-release, delayed-release & modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition evaluation, robustness studies
• Compliance with Ph. Eur. & EU MA requirements

✅ Residual Solvents Method Validation

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

Products Covered – Cyprus / EU

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

Regulatory Compliance – Cyprus

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• EMA / EU Guidelines
• European Pharmacopoeia (Ph. Eur.)
• ICH Q3A / Q3B / Q3C / Q3D
• EU GMP (EudraLex – Volume 4)
• Cyprus Pharmaceutical Services (MoH) requirements

Post-Submission Regulatory Support – Cyprus

VALIDEX provides complete regulatory query management, including:

✅ Responses to Cyprus MoH / EMA deficiency letters
✅ Scientific justification for analytical and validation parameters
✅ Data gap assessment & corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during GMP inspections & EU regulatory audits

Why Choose VALIDEX for Cyprus & EU?

✔ Strong understanding of Cyprus national & EU regulatory pathways
✔ ICH-aligned, EMA-focused documentation strategy
✔ Inspection-ready and audit-compliant validation reports
✔ Experience supporting DCP / MRP / Centralized EU submissions
✔ Fast turnaround timelines
✔ Strict confidentiality & data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Cyprus

• EU-compliant Analytical Method Validation Protocols
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• EU CTD (Modules 2 & 3) analytical summaries
• Cyprus / EMA regulatory query response packages
• Method transfer, verification & re-validation documentation

Industries We Serve – Cyprus

• Marketing Authorization Holders (MAHs)
• API manufacturers supplying to the EU
• Generic & branded formulation companies
• Contract Manufacturing Organizations (CMOs)
• Multinational pharmaceutical companies
• Regulatory & dossier consulting firms

EU Market Access Support – Cyprus

VALIDEX supports Analytical Method Validation for:

• Cyprus national marketing authorization
• DCP / MRP EU submissions
• Centralized EMA procedures
• EU lifecycle management & post-approval variations
• Export dossiers prepared for Cyprus & EU markets

Partner with VALIDEX – Cyprus

Achieve EU-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Cyprus and the European Union.