🇸🇨 Analytical Method Validation Services – Seychelles

Ensuring Accuracy. Compliance. Regulatory Confidence for Seychelles 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 in full compliance with Seychelles' regulatory requirements.

We support pharmaceutical importers and suppliers across Seychelles with compliance aligned with the Ministry of Health (MoH), ICH-aligned documentation, and post-submission handling of queries for drug registration, licensing, and import requirements via the relevant health authorities.

🇸🇨 Our Core Expertise – Seychelles Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Seychelles Ministry of Health and internationally accepted standards, heavily reliant on guidelines from WHO, PIC/S, and major international pharmacopoeias due to the country's small market size.

• ✅ Assay Method Validation

  • Potency and content determination

  • Validation as per ICH Q2 (R1 / R2) aligned with international quality expectations

  • Accuracy, precision, linearity, robustness, and specificity

  • BP/USP/EP harmonized methods

• ✅ Impurities Method Validation

  • Related substances & degradation product profiling

  • Identification and quantification of impurities

  • Stability-indicating method validation as per ICH and WHO-GMP

• ✅ Dissolution Method Validation

  • Immediate & modified release products

  • Discriminatory dissolution method development

  • Media selection, sink condition assessment, and method robustness

  • Compliance with product registration requirements, following international norms.

• ✅ Residual Solvents Method Validation

  • Gas Chromatographic (GC) method validation

  • Compliance with ICH Q3C adopted globally

  • Class I, II & III residual solvents

  • Limits, system suitability, accuracy, and precision

🇸🇨 Products Covered – Seychelles

• ✅ Active Pharmaceutical Ingredients (APIs)

• ✅ Oral solid dosage forms (tablets, capsules, sachets)

• ✅ Injectable formulations (sterile & non-sterile)

• ✅ Semi-solid & liquid dosage forms

• ✅ Modified & controlled release products

🇸🇨 Regulatory Compliance – Seychelles

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)

• Ministry of Health requirements and national legislation related to medicines control

• WHO-GMP recommendations, which serve as the primary quality benchmark

• British Pharmacopoeia (BP) (historically referenced)

• United States Pharmacopeia (USP)

• European Pharmacopoeia (EP)

🇸🇨 Post-Submission Regulatory Support (Seychelles)

VALIDEX provides complete regulatory query management, assisting with responses to the Ministry of Health and other competent authorities, including:

• ✅ Response to regulatory deficiency letters

• ✅ Scientific justification for validation parameters

• ✅ Data gap assessment & corrective documentation

• ✅ Revised validation protocols and reports

• ✅ Technical support during regulatory inspections & audits

🇸🇨 Why Choose VALIDEX for Seychelles?

• ✔ Strong understanding of Seychelles' regulatory reliance on international standards (WHO, PIC/S)

• ✔ ICH-aligned documentation focused on international 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 – Seychelles

• Analytical Method Validation Protocols (Internationally compliant)

• Validation Reports for:

  • Assay

  • Impurities

  • Dissolution

  • Residual Solvents

• CTD / Non-CTD summary documents for Ministry of Health submissions

• Regulatory query response packages

• Method transfer & verification documentation

🇸🇨 Industries We Serve in Seychelles

• Pharmaceutical importers and distributors

• API traders and suppliers

• International generic formulation companies supplying the market

• Contract Manufacturing Organizations (CMOs) exporting to Seychelles

• Regulatory & dossier consulting firms

🇸🇨 National & Export Support

VALIDEX supports Analytical Method Validation for:

• Seychelles domestic approvals (Product registration)

• Licensing and tender submissions

• Export dossiers for international shipment

🇸🇨 Partner with VALIDEX – Seychelles

Achieve regulatory-ready analytical validation with confidence.

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