Analytical Method Validation Services – Panama

Ensuring Accuracy. Compliance. Regulatory Confidence for Panama Regulatory 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 Panama regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Panama with MINSA / DNFD-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of regulatory queries for sanitary registration (Registro Sanitario), manufacturing/import approvals, and export dossiers.

Our Core Expertise – Panama Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Ministry of Health (MINSA), Republic of Panama, through the Directorate of Pharmacy and Drugs (DNFD).

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by MINSA Panama
• Accuracy, precision, linearity, robustness, and specificity
• USP / BP / Ph. Eur. / IP harmonized analytical methods

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of impurities
• Stability-indicating method validation aligned with MINSA & WHO expectations
• Compliance with ICH Q3A / Q3B / Q3D (elemental impurities) and pharmacopoeial limits

✅ Dissolution Method Validation

• Immediate-release and modified-release dosage forms
• Discriminatory dissolution method development
• Media selection, sink condition assessment, and robustness studies
• Compliance with Panama sanitary registration and post-approval variation requirements

✅ Residual Solvents Method Validation

• Gas Chromatographic (GC) method validation
• Compliance with ICH Q3C adopted by Panama
• Class I, II & III residual solvents
• Limits, system suitability, accuracy, and precision

Products Covered – Panama

✅ 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 controlled-release products

Regulatory Compliance – Panama

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• MINSA / DNFD Drug Registration & Technical Requirements
• Panama Health Code (Código Sanitario de Panamá)
• Central American Technical Regulations (RTCA) where applicable
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by MINSA
• USP / BP / Ph. Eur. Pharmacopoeial Standards

Post-Submission Regulatory Support – Panama

VALIDEX provides complete MINSA / DNFD query management, including:

✅ Responses to deficiency letters and technical evaluation queries
✅ Scientific justification for validation parameters
✅ Data gap assessment and corrective documentation
✅ Revised validation protocols and reports
✅ Technical support during MINSA dossier reviews, inspections, and audits

Why Choose VALIDEX for Panama?

✔ Strong understanding of Panama & Central America regulatory expectations
✔ ICH-aligned, WHO-compliant documentation
✔ Inspection-ready and audit-compliant validation reports
✔ Fast turnaround timelines
✔ Strict confidentiality and data integrity
✔ Single-window scientific and regulatory support under Zoesoe Exports Pvt Ltd

Our Deliverables – Panama

• Analytical Method Validation Protocols (MINSA-compliant)
• Validation Reports for:
o Assay
o Impurities
o Dissolution
o Residual Solvents
• CTD / Non-CTD summary documents for Panama submissions
• Regulatory query response packages
• Method transfer, verification, and re-validation documentation

Industries We Serve in Panama

• Pharmaceutical manufacturing companies
• API manufacturers
• Generic and branded formulation companies
• Contract Manufacturing Organizations (CMOs)
• Importers, distributors, and MAHs
• Regulatory and dossier consulting firms

National & Export Support – Panama

VALIDEX supports Analytical Method Validation for:

• Panama domestic product registration (Registro Sanitario – MINSA)
• Manufacturing and import authorization applications
• Export dossiers prepared for Panama, Central America, and WHO-referenced markets

Partner with VALIDEX – Panama

Achieve MINSA-ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Panama.