🇩🇪 Analytical Method Validation Services – Germany

Sicherstellung von Analytischer Präzision, Konformität und Regulatorischer Verlässlichkeit für Einreichungen beim BfArM/PEI (Ensuring Analytical Precision, Compliance, and Regulatory Reliability for Submissions to BfArM/PEI)

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 Germany's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across Germany with compliance aligned with the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM) and the Paul-Ehrlich-Institut (PEI) (for biologicals), ICH-aligned documentation, and post-submission handling of national queries for Marketing Authorization (MA), manufacturing licenses, and EU/EEA requirements.

🇩🇪 Our Core Expertise – Germany Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the BfArM/PEI and the stringent standards of the European Union (EU). Germany, as a major EU member state, strictly adheres to the European Pharmacopoeia (Ph. Eur.) and the latest ICH guidelines (including Q2(R2) and Q14).

• ✅ Assay Method Validation (Validierung der Gehaltsbestimmungsmethode)

  • Potency and content determination.

  • Validation strictly as per ICH Q2 (R1 / R2) aligned with BfArM/PEI and EMA/EU 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 EU GMP 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 EU CTD format.

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

  • 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 – Germany

• ✅ Chemical Drug Substances and Products (BfArM scope)

• ✅ Vaccines and Biomedical Drugs (PEI scope)

• ✅ Oral solid dosage forms (tablets, capsules)

• ✅ Injectable formulations (sterile & non-sterile)

• ✅ Semi-solid & liquid dosage forms

🇩🇪 Regulatory Compliance – Germany

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2) and the new lifecycle approach of ICH Q14.

• BfArM and PEI Regulations, and the German Medicinal Products Act (Arzneimittelgesetz - AMG).

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

• EU Good Manufacturing Practices (GMP).

🇩🇪 Post-Submission Regulatory Support (Germany)

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

• ✅ Response to regulatory deficiency letters (e.g., from BfArM's Quality Assessment team).

• ✅ Scientific justification for validation parameters, including demonstration of Analytical Quality by Design (AQbD) principles where applicable.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports (Module 3 quality section).

• ✅ Technical support during BfArM/PEI/EU inspections & audits.

🇩🇪 Why Choose VALIDEX for Germany?

• ✔ Deep understanding of the BfArM's and PEI's specialized roles and their interpretation of EU and ICH guidelines (e.g., for batch release by PEI's OMCL function).

• ✔ Expertise in preparing documentation for the stringent eCTD submissions required by German federal agencies.

• ✔ Adoption of the new ICH Q2(R2) and Q14 standards for lifecycle management.

• ✔ Inspection-ready and audit-compliant validation reports.

• ✔ Fast turnaround timelines and strict confidentiality.

🇩🇪 Our Deliverables – Germany

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

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation (e.g., section 3.2.S.4.3 / 3.2.P.5.3) for BfArM/PEI submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇩🇪 Industries We Serve in Germany

• Pharmaceutical manufacturing companies.

• API manufacturers and importers.

• Biotech/Vaccine manufacturers (PEI-regulated products).

• Generic formulation companies.

• Contract Manufacturing Organizations (CMOs/CROs).

• Import and Distribution companies.

🇩🇪 National & Export Support

VALIDEX supports Analytical Method Validation for:

• Germany domestic approvals (Market Authorization from BfArM/PEI).

• Manufacturing licenses & product permissions.

• Export dossiers within the EU/EEA and globally.

🇩🇪 Partner with VALIDEX – Germany

Achieve BfArM/PEI-ready analytical validation with confidence.

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