Analytical Method Validation Services – Zanzibar

ZFDA-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides comprehensive Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling, specifically aligned with the regulatory framework of the Zanzibar Food and Drug Agency (ZFDA).

All studies are conducted according to ZFDA Guidelines, WHO TRS, ICH standards, GCP, and GLP, ensuring acceptance for Zanzibar’s drug registration and international submissions.

💊 Core Services for Zanzibar (ZFDA) Regulatory Submissions

Clinical BA/BE Studies (Human)

• Study Designs: Single-dose & multiple-dose BA/BE studies using crossover or parallel designs accepted by ZFDA.
• Volunteer Selection: Healthy subjects or patient cohorts depending on the drug category.
• Ethics Approval: Required from the Zanzibar Health Research Institute (ZHRI) Ethics Committee or another recognized IRB.
• Protocol Development: ZFDA-aligned protocols prepared according to ICH E6 (R2) GCP and WHO TRS recommendations.

Comparative Dissolution Profiling (CDP)

• Regulatory Requirement: Mandatory for generic submissions, variations, and post-approval quality equivalence testing.
• Dissolution Media: Pharmacopeial & biorelevant media used to meet ZFDA expectations.
• Similarity Factor: f2 similarity factor calculated for comparing dissolution profiles.
• Evaluation Methods: Includes both model-independent (f1, f2) and model-dependent modeling.

IVIVC & Biowaiver Support

• BCS-Based Biowaiver: Prepared per WHO TRS, ICH Q6A, and ZFDA-compatible scientific principles.
• IVIVC Models: Level A, B, and C predictive in vitro–in vivo correlation models.
• Predictive PK Modeling: Used for regulatory justification of biowaiver applications.

Analytical Method Development & Validation

• Platforms: LC-MS/MS and HPLC-UV analytical systems for drug quantification.
• Validation: Conducted according to ICH M10, WHO TRS, and validation requirements recognized by ZFDA.
• Stability-Indicating Methods: Developed for APIs and finished pharmaceutical products.

Pharmacokinetic (PK) Analysis

• PK Approach: Non-compartmental analysis (NCA).
• Statistical BE Evaluation: Conducted using WHO and ICH harmonized statistical principles accepted by ZFDA.
• Sample Size & Power: Scientifically determined for conclusive BE outcomes.

📑 ZFDA-Ready Regulatory Documentation

We prepare complete documentation suitable for submission to the Zanzibar Food and Drug Agency (ZFDA), including:

• Clinical Study Protocol (Zanzibar-compliant)
• Informed Consent Forms (ICF) aligned with Zanzibar’s ethical requirements
• Investigator Brochure
• Clinical Study Report (CSR) following ICH & WHO TRS
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile Report
• CTD/ACTD Modules (1–5) formatted for ZFDA submissions

✨ Why Choose BioEquiGlobal for the Zanzibar Market?

• ZFDA-Focused Expertise: All BA/BE study protocols, dissolution profiles, PK analyses, and CTD dossiers developed according to ZFDA standards.
• High Global Standards: Operations fully compliant with GCP, GLP, ICH, and WHO TRS guidelines, supported by robust QA.
• Advanced Infrastructure: Accredited clinical facilities and high-performance analytical laboratories (including NABL-certified labs where applicable).
• Global Regulatory Experience: CTD/ACTD dossier preparation for ZFDA and other global agencies (US FDA, EMA, MHRA, TGA, GCC, SAHPRA, etc.).

🗺️ BA/BE Study Workflow for Zanzibar (ZFDA)

1. Feasibility & Gap Assessment: Evaluation of reference drug availability, dissolution suitability, and biowaiver potential.

2. Protocol Development: Drafting ZFDA-compliant BA/BE protocols and facilitating ZHRI Ethics Committee approval.

3. Analytical Method Development: LC-MS/MS method development and validation per ICH M10 & WHO TRS.

4. Clinical Study Execution: GCP-supervised subject recruitment, dosing, sampling, and safety monitoring.

5. Bioanalysis & PK Evaluation: PK modeling, QC checks, and statistical BE evaluation.

6. Documentation & Submission: Preparation of ZFDA-ready CSR, dissolution reports, validation packages, and CTD/ACTD modules.

Who We Support

• Pharmaceutical manufacturers targeting Zanzibar’s ZFDA market
• CROs needing BA/BE or analytical outsourcing
• Regulatory teams requiring ZFDA-compliant CTD/ACTD dossiersEnsuring Accuracy. Compliance. Regulatory Confidence for Zanzibar 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 Zanzibar regulatory requirements.

We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Zanzibar with ZFDA-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of Zanzibar Food and Drug Agency (ZFDA) queries for product registration, marketing authorization, import permits, and export dossiers.

Our Core Expertise – Zanzibar Focus

VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Zanzibar Food and Drug Agency (ZFDA) under the Ministry of Health, Revolutionary Government of Zanzibar.

✅ Assay Method Validation

• Potency and content determination
• Validation as per ICH Q2 (R1 / R2) accepted by ZFDA Zanzibar
• Accuracy, precision, linearity, robustness, and specificity
• USP / BP / EP / IP harmonized analytical methods

✅ Impurities Method Validation

• Related substances and degradation product profiling
• Identification and quantification of impurities
• Stability-indicating method validation aligned with ZFDA & 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 ZFDA product registration and post-approval variation requirements

✅ Residual Solvents Method Validation

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

Products Covered – Zanzibar

✅ 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 – Zanzibar

All Analytical Method Validation activities are conducted in accordance with:

• ICH Q2 (R1 / R2)
• ZFDA Registration Guidelines & Technical Requirements
• Zanzibar Food, Drugs and Cosmetics Act
• WHO Technical Report Series (TRS)
• WHO-GMP Guidelines (recognized by ZFDA)
• USP / BP / EP Pharmacopoeial Standards

Post-Submission Regulatory Support – Zanzibar

VALIDEX provides complete ZFDA query management, including:

✅ Responses to ZFDA 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 ZFDA dossier reviews, inspections, and audits

Why Choose VALIDEX for Zanzibar?

✔ Strong understanding of ZFDA regulatory expectations
✔ ICH-aligned, WHO-compliant documentation accepted in Zanzibar
✔ 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 – Zanzibar

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

Industries We Serve in Zanzibar

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

National & Export Support – Zanzibar

VALIDEX supports Analytical Method Validation for:

• Zanzibar domestic product registration (ZFDA)
• Import permits and marketing authorization applications
• Export dossiers prepared for ZFDA-regulated and WHO-referenced markets

Partner with VALIDEX – Zanzibar

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