🇨🇭 Analytical Method Validation Services – Switzerland

Gewährleistung von Analytischer Präzision, Konformität und Regulatorischer Verlässlichkeit für Einreichungen bei Swissmedic (Ensuring Analytical Precision, Compliance, and Regulatory Reliability for Submissions to Swissmedic)

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 Switzerland's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Switzerland with compliance aligned with Swissmedic (the Swiss Agency for Therapeutic Products), ICH-aligned documentation, and post-submission handling of Swissmedic queries for Marketing Authorization (MA), manufacturing licenses, and national/international requirements.

🇨🇭 Our Core Expertise – Switzerland Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by Swissmedic. Switzerland maintains a rigorous, high-quality standard, strongly following ICH guidelines (as an ICH founding member) and major pharmacopoeias (Ph. Eur./USP).

• ✅ Assay Method Validation (Validierung der Gehaltsbestimmungsmethode)

  • Potency and content determination

  • Validation strictly as per ICH Q2 (R1 / R2) aligned with Swissmedic expectations.

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

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

• ✅ Impurities Method Validation (Validierung der Verunreinigungsmethode)

  • Related substances & degradation product profiling.

  • Identification and quantification of impurities.

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

• ✅ Dissolution Method Validation (Validierung der Auflösungsmethode)

  • Immediate & modified release products.

  • Discriminatory dissolution method development.

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

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

• ✅ Residual Solvents Method Validation (Validierung der Methode für Restlösungsmittel)

  • Gas Chromatographic (GC) method validation.

  • Compliance with ICH Q3C (adopted by Swissmedic).

  • Class I, II & III residual solvents.

  • Limits, system suitability, accuracy, and precision.

🇨🇭 Products Covered – Switzerland

• ✅ Active Pharmaceutical Ingredients (APIs)

• ✅ Oral solid dosage forms (tablets, capsules)

• ✅ Injectable formulations (sterile & non-sterile)

• ✅ Semi-solid & liquid dosage forms

• ✅ Biotechnological/Biological products (following specific Swissmedic requirements).

🇨🇭 Regulatory Compliance – Switzerland

All Analytical Method Validation activities are conducted in accordance with:

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

• Swissmedic Guidelines and the Therapeutic Products Act (TPA).

• European Pharmacopoeia (Ph. Eur.) and United States Pharmacopeia (USP).

• Swiss Good Manufacturing Practices (GMP) (aligned with EU/PIC/S standards).

🇨🇭 Post-Submission Regulatory Support (Switzerland)

VALIDEX provides complete regulatory query management, assisting with responses to Swissmedic queries and technical review requirements, including:

• ✅ Response to Swissmedic deficiency letters (often regarding Module 3 quality data).

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

• ✅ Technical support during Swissmedic inspections & audits.

🇨🇭 Why Choose VALIDEX for Switzerland?

• ✔ Strong understanding of Swissmedic's status as a highly respected, independent regulatory body with stringent quality expectations.

• ✔ ICH-aligned documentation prepared to meet the high standards of a founding ICH member.

• ✔ 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 – Switzerland

• Analytical Method Validation Protocols (Swissmedic-compliant).

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for Swissmedic submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇨🇭 Industries We Serve in Switzerland

• Pharmaceutical manufacturing companies (especially those involved in R&D and high-value APIs/biologics).

• 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:

• Switzerland domestic approvals (Market Authorization from Swissmedic).

• Manufacturing licenses & product permissions.

• Export dossiers globally.

🇨🇭 Partner with VALIDEX – Switzerland

Achieve Swissmedic-ready analytical validation with confidence.

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