Analytical Method Validation Services – Canada
Ensuring Accuracy. Compliance. Regulatory Confidence for Health Canada 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 Canadian regulatory requirements.
We support pharmaceutical manufacturers, MAHs, API manufacturers, CMOs, and exporters targeting Canada with Health Canada–compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Health Canada queries for NDS, ANDS, SNDS, DIN applications, DMFs, and export dossiers.
Our Core Expertise – Canada Focus
VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by Health Canada (HPFB), in alignment with ICH guidance and Canadian cGMP expectations.
✅ Assay Method Validation
• Potency, content, and strength determination
• Validation as per ICH Q2 (R1 / R2) accepted by Health Canada
• Accuracy, precision (repeatability & intermediate precision), linearity, range, robustness, and specificity
• USP / BP / Ph. Eur. / IP harmonized analytical methods
✅ Impurities Method Validation
• Related substances, degradation products, and process impurities
• Identification, qualification, and quantification of impurities
• Stability-indicating method validation aligned with Health Canada & ICH expectations
• Compliance with ICH Q3A / Q3B / Q3C / Q3D (including elemental impurities)
✅ Dissolution Method Validation
• Immediate-release, delayed-release, and modified-release products
• Discriminatory dissolution method development
• Media selection, sink condition evaluation, and robustness studies
• Compliance with USP <711>, Health Canada guidance, and ANDS/NDS expectations
✅ Residual Solvents Method Validation
• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C and USP <467>
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, precision, LOD/LOQ
Products Covered – Canada
✅ 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 complex formulations
✅ Combination products (where applicable)
Regulatory Compliance – Canada
All Analytical Method Validation activities are conducted in accordance with:
• ICH Q2 (R1 / R2)
• Health Canada Guidance – Quality (Chemistry & Manufacturing)
• Food and Drugs Act & Food and Drug Regulations (Canada)
• Canadian cGMP – GUI-0001
• USP–NF / BP / Ph. Eur. Pharmacopoeial Standards
• Health Canada Data Integrity & ALCOA+ principles
• WHO Technical Report Series (TRS) (where applicable)
Post-Submission Regulatory Support – Canada
VALIDEX provides complete Health Canada query and lifecycle management, including:
✅ Responses to Screening Deficiency Notices (SDN), Clarifaxes, and IRs
✅ Scientific justification for validation approaches
✅ Data gap assessment and remediation support
✅ Revised validation protocols and reports
✅ Technical support during Health Canada inspections and GMP audits
Why Choose VALIDEX for Canada?
✔ Strong understanding of Health Canada reviewer expectations
✔ ICH-aligned, Canada-focused documentation
✔ Inspection-ready and audit-defensible validation reports
✔ Experience with NDS, ANDS, SNDS, DMF, and DIN filings
✔ Fast turnaround timelines
✔ Strict confidentiality & data integrity compliance
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd
Our Deliverables – Canada
• Health Canada–compliant Analytical Method Validation Protocols
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD Module 3 documentation (2.3 & 3.2.S / 3.2.P)
• NDS / ANDS / DMF validation summaries
• Health Canada query response packages
• Method transfer, verification, and re-validation documentation
Industries We Serve in Canada
• Pharmaceutical manufacturing companies
• API manufacturers & DMF holders
• Generic drug companies (ANDS applicants)
• Innovator companies (NDS / SNDS sponsors)
• Contract Manufacturing Organizations (CMOs)
• Regulatory & dossier consulting firms
National & Global Export Support – Canada
VALIDEX supports Analytical Method Validation for:
• Health Canada domestic submissions
• NDS / ANDS / SNDS / DMF filings
• Export dossiers prepared for Canada, U.S., EU, and WHO-referenced markets
• Method validation bridging for Canada–US–EU regulatory alignment
Partner with VALIDEX – Canada
Achieve Health Canada–ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Canada.