Analytical Method Validation Services – Costa Rica

Ensuring Accuracy. Compliance. Regulatory Confidence for Costa Rica 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 Costa Rica regulatory requirements.

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

Our Core Expertise – Costa Rica Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Ministry of Health (Ministerio de Salud), Republic of Costa Rica.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by Costa Rica health authorities
• 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 Ministry of Health & WHO expectations
• Compliance with ICH Q3A / Q3B and pharmacopoeial impurity 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 Costa Rica sanitary registration and post-approval variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Costa Rica

✅ 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 – Costa Rica

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• Ministry of Health (Ministerio de Salud) Registration Requirements
• General Health Law of Costa Rica (Ley General de Salud)
• Central American Technical Regulations (RTCA), where applicable
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by Costa Rica
• USP / BP / Ph. Eur. Pharmacopoeial Standards

Post-Submission Regulatory Support – Costa Rica

VALIDEX provides complete regulatory query management, including:

✅ Responses to Ministry of Health 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 dossier reviews, inspections, and audits

Why Choose VALIDEX for Costa Rica?

✔ Strong understanding of Costa Rica 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 – Costa Rica

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

Industries We Serve in Costa Rica

• 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 – Costa Rica

VALIDEX supports Analytical Method Validation for:

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

Partner with VALIDEX – Costa Rica

Achieve Ministry of Health–ready analytical validation with confidence.
From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Costa Rica.