🇵🇪 Bioavailability & Bioequivalence (BA/BE) Studies Services for Peru

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

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

Our Core Expertise – Peru Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) under the Ministry of Health (MINSA), Republic of Peru.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by DIGEMID Peru
• 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 DIGEMID & 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 Peru product registration and post-approval variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Peru

✅ 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 – Peru

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• DIGEMID Registration & Technical Requirements
• Peruvian General Health Law (Ley General de Salud)
• Andean Community (CAN) regulatory principles, where applicable
• WHO Technical Report Series (TRS)
• WHO-GMP principles recognized by DIGEMID
• USP / BP / Ph. Eur. Pharmacopoeial Standards

Post-Submission Regulatory Support – Peru

VALIDEX provides complete DIGEMID query management, including:

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

Why Choose VALIDEX for Peru?

✔ Strong understanding of DIGEMID & Andean/Latin 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 – Peru

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

Industries We Serve in Peru

• 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 – Peru

VALIDEX supports Analytical Method Validation for:

• Peru domestic product registration (Registro Sanitario – DIGEMID)
• Manufacturing and import authorization applications
• Export dossiers prepared for Peru, Andean Community markets, and WHO-referenced markets

Partner with VALIDEX – Peru

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