🇱🇹 Analytical Method Validation Services – Lithuania

Užtikriname Tikslumą, Atitiktį ir Reguliavimo Pasitikėjimą Pasiūlymams VVKT (Ensuring Accuracy, Compliance, and Regulatory Confidence for Submissions to VVKT)

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 Lithuania's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Lithuania with compliance aligned with the State Medicines Control Agency (Valstybinė vaistų kontrolės tarnyba - VVKT), ICH-aligned documentation, and post-submission handling of VVKT queries for Marketing Authorization (MA), manufacturing licenses, and EU/EEA requirements.

🇱🇹 Our Core Expertise – Lithuania Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the VVKT and the stringent standards of the European Union (EU). Lithuania, as an EU member state, strictly adheres to the European Pharmacopoeia (Ph. Eur.) and ICH guidelines.

• ✅ Assay Method Validation (Analizės Metodo Validavimas Turinio Nustatymui)

  • Potency and content determination

  • Validation strictly as per ICH Q2 (R1 / R2) aligned with VVKT and EMA/EU expectations.

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

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

• ✅ Impurities Method Validation (Analizės Metodo Validavimas Priemaišų Nustatymui)

  • Related substances & degradation product profiling.

  • Identification and quantification of impurities.

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

• ✅ Dissolution Method Validation (Analizės Metodo Validavimas Išsiskyrimui)

  • Immediate & modified release products.

  • Discriminatory dissolution method development.

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

  • Compliance with product registration requirements, submitted in EU CTD format.

• ✅ Residual Solvents Method Validation (Analizės Metodo Validavimas Likutiniams Tirpikliams)

  • Gas Chromatographic (GC) method validation.

  • Compliance with ICH Q3C (adopted by the EU).

  • Class I, II & III residual solvents.

  • Limits, system suitability, accuracy, and precision.

🇱🇹 Products Covered – Lithuania

• ✅ Active Pharmaceutical Ingredients (APIs)

• ✅ Oral solid dosage forms (tablets, capsules)

• ✅ Injectable formulations (sterile & non-sterile)

• ✅ Semi-solid & liquid dosage forms

• ✅ Modified & controlled release products

🇱🇹 Regulatory Compliance – Lithuania

All Analytical Method Validation activities are conducted in accordance with:

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

• VVKT (State Medicines Control Agency) Regulations and national pharmaceutical laws.

• European Pharmacopoeia (Ph. Eur.) and relevant EU Directives/Regulations.

• EU Good Manufacturing Practices (GMP).

• United States Pharmacopeia (USP) and British Pharmacopoeia (BP) (where applicable).

🇱🇹 Post-Submission Regulatory Support (Lithuania)

VALIDEX provides complete regulatory query management, assisting with responses to VVKT (and potentially EMA for centralized procedures) queries and technical review requirements, including:

• ✅ Response to VVKT deficiency letters (trūkumai).

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

• ✅ Technical support during VVKT/EU inspections & audits.

🇱🇹 Why Choose VALIDEX for Lithuania?

• ✔ Strong understanding of the VVKT's regulatory interpretation and strict adherence to EU/EMA standards, often aligning with Baltic and Nordic best practices.

• ✔ ICH-aligned documentation focused on European national 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 – Lithuania

• Analytical Method Validation Protocols (EU/VVKT-compliant).

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for VVKT submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇱🇹 Industries We Serve in Lithuania

• Pharmaceutical manufacturing companies.

• API manufacturers and importers.

• Generic formulation companies.

• Contract Manufacturing Organizations (CMOs).

• Import and Distribution companies.

• Regulatory & dossier consulting firms.

🇱🇹 National & Export Support

VALIDEX supports Analytical Method Validation for:

• Lithuania domestic approvals (Market Authorization from VVKT).

• Manufacturing licenses & product permissions.

• Export dossiers within the EU/EEA and internationally.

🇱🇹 Partner with VALIDEX – Lithuania

Achieve VVKT-ready analytical validation with confidence.

From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner in Lithuania.