Analytical Method Validation Services – Romania

Ensuring Accuracy. Compliance. Regulatory Confidence for Romania & EU 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 Romanian and European Union regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Romania and the EU with ANMDMR-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of ANMDMR / EMA-related regulatory queries for national, MRP/DCP, and EU regulatory procedures.

Our Core Expertise – Romania Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the National Agency for Medicines and Medical Devices of Romania (ANMDMR) and aligned with European Medicines Agency (EMA) expectations.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) adopted by EMA & ANMDMR Romania
• Accuracy, precision, linearity, robustness, and specificity
• European Pharmacopoeia (Ph. Eur.) / USP / BP harmonized analytical methods

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of impurities
• Stability-indicating method validation aligned with EMA & ICH expectations
• Compliance with ICH Q3A / Q3B / Q3D (elemental impurities) and 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 EMA / Ph. Eur. product approval requirements

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C as implemented in the EU
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, and precision

Products Covered – Romania

✅ 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 – Romania

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• EMA Guidelines on Analytical Procedures & Validation
• ANMDMR Registration & Technical Requirements
• EU Directive 2001/83/EC & Regulation (EC) No 726/2004
• EU-GMP (EudraLex Volume 4)
• European Pharmacopoeia (Ph. Eur.)
• WHO Technical Report Series (where applicable)

Post-Submission Regulatory Support – Romania / EU

VALIDEX provides complete regulatory query management, including:

✅ Responses to ANMDMR, RMS/CMS, and EMA deficiency letters
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during EU-GMP inspections and regulatory audits

Why Choose VALIDEX for Romania?

✔ Strong understanding of Romanian & EU regulatory expectations
✔ ICH-aligned, EMA-compliant 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 – Romania

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

Industries We Serve in Romania

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic and branded formulation companies
• Contract Manufacturing Organizations (CMOs)
• EU importers and MAHs
• Regulatory and dossier consulting firms

National & EU Export Support – Romania

VALIDEX supports Analytical Method Validation for:

• Romania national registrations (ANMDMR)
• EU MRP / DCP / Centralised procedures
• Export dossiers prepared for EU and EMA-regulated markets

Partner with VALIDEX – Romania

Achieve ANMDMR- and EMA-ready analytical validation with confidence.
From method validation to EU regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Romania and Europe.