🇬🇧 Analytical Method Validation Services – United Kingdom

Ensuring Accuracy, Compliance, and Regulatory Confidence for Submissions to the MHRA

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 United Kingdom's regulatory requirements.

We support pharmaceutical manufacturers and suppliers across the UK with compliance aligned with the Medicines and Healthcare products Regulatory Agency (MHRA), ICH-aligned documentation, and post-submission handling of MHRA queries for Marketing Authorization (MA), manufacturing licenses, and national/international requirements.

🇬🇧 Our Core Expertise – United Kingdom Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the MHRA (UK's competent authority). Post-Brexit, the MHRA maintains strong alignment with the British Pharmacopoeia (BP) and ICH guidelines.

• ✅ Assay Method Validation

  • Potency and content determination

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

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

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

• ✅ Impurities Method Validation

  • Related substances & degradation product profiling.

  • Identification and quantification of impurities.

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

• ✅ Dissolution Method Validation

  • 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

  • Gas Chromatographic (GC) method validation.

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

  • Class I, II & III residual solvents.

  • Limits, system suitability, accuracy, and precision.

🇬🇧 Products Covered – United Kingdom

• ✅ 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 – United Kingdom

All Analytical Method Validation activities are conducted in accordance with:

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

• MHRA (Medicines and Healthcare products Regulatory Agency) Rules and Guidance.

• British Pharmacopoeia (BP) and European Pharmacopoeia (Ph. Eur.).

• UK Good Manufacturing Practices (GMP).

• Relevant EU legislation as retained in UK law.

🇬🇧 Post-Submission Regulatory Support (United Kingdom)

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

• ✅ Response to MHRA deficiency letters (often focusing on CMC data in Module 3).

• ✅ Scientific justification for validation parameters.

• ✅ Data gap assessment & corrective documentation.

• ✅ Revised validation protocols and reports.

• ✅ Technical support during MHRA inspections & audits.

🇬🇧 Why Choose VALIDEX for the United Kingdom?

• ✔ Strong understanding of the MHRA's current regulatory framework, especially post-EU exit.

• ✔ ICH-aligned documentation focused on UK 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 – United Kingdom

• Analytical Method Validation Protocols (MHRA-compliant).

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD Module 3 documentation for MHRA submissions.

• Regulatory query response packages.

• Method transfer & verification documentation.

🇬🇧 Industries We Serve in the UK

• 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:

• UK domestic approvals (Marketing Authorization from MHRA).

• Manufacturing licenses & product permissions.

• Export dossiers globally.

🇬🇧 Partner with VALIDEX – United Kingdom

Achieve MHRA-ready analytical validation with confidence.

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