Analytical Method Validation Services – Côte d’Ivoire

• DPML-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 aligned with the regulatory requirements of Côte d’Ivoire’s Direction de la Pharmacie, du Médicament et des Laboratoires (DPML).

  All studies strictly follow DPML Guidelines, ICH, WHO TRS, GCP, GLP, ensuring regulatory acceptability for national submissions and global markets.

  💊 Core Services for Côte d’Ivoire (DPML) Regulatory Submissions

  Clinical BA/BE Studies (Human)

  • Study Designs: Single-dose and multiple-dose BA/BE studies using crossover or parallel designs approved by DPML.
  • Volunteer Selection: Healthy volunteers or patient-based studies depending on therapeutic context.
  • Ethics Approval: Required approval from a recognized Comité National d’Éthique/IRB in Côte d’Ivoire.
  • Protocol Development: DPML-aligned BA/BE protocols developed according to ICH E6 (R2) GCP and WHO TRS.

  Comparative Dissolution Profiling (CDP)

  • Regulatory Requirement: Required for generic medicine registration, variations, and quality assessments.
  • Dissolution Media: Pharmacopeial and biorelevant media.
  • Similarity Assessment: f2 similarity factor to compare test vs. reference dissolution profiles.
  • Evaluation Approaches: Both model-independent (f1, f2) and model-dependent dissolution evaluation.

  IVIVC & Biowaiver Support

  • BCS-Based Biowaiver: Designed according to WHO TRS, ICH Q6A, and DPML-accepted scientific criteria.
  • IVIVC Models: Level A, B, and C predictive correlation models.
  • Predictive PK Modeling: Supports biowaiver justification and BE conclusions.

  Analytical Method Development & Validation

  • Platforms: LC-MS/MS and HPLC-UV used for precise drug quantification.
  • Validation: Conducted as per ICH M10, WHO TRS, and DPML-compatible analytical validation standards.
  • Stability Methods: Development of stability-indicating methods for APIs and finished dosage forms.

  Pharmacokinetic (PK) Analysis

  • PK Approach: Non-compartmental analysis (NCA).
  • Statistical BE Evaluation: Following ICH and WHO harmonized BE methods recognized by DPML.
  • Study Power & Sample Size: Designed to ensure conclusive BE demonstration.

  📑 DPML-Ready Regulatory Documentation

  We prepare full drug registration documentation aligned with Côte d’Ivoire’s Direction de la Pharmacie, du Médicament et des Laboratoires, including:

  • Clinical Study Protocol (DPML-compliant)
  • Informed Consent Forms (ICF) per national ethical requirements
  • Investigator Brochure
  • Clinical Study Report (CSR) following ICH & WHO TRS guidelines
  • Bioanalytical Method Validation Report
  • Comparative Dissolution Profile Report
  • CTD/ACTD Modules formatted for DPML submissions

  ✨ Why Choose BioEquiGlobal for the Ivorian Market?

  • Regulatory Expertise: BA/BE study designs, PK reports, dissolution profiles, and CTD dossiers tailored to DPML expectations.
  • International Standards: All processes follow GCP, GLP, ICH, and WHO requirements, supported by strong internal QA.
  • Advanced Facilities: Accredited clinical units and high-precision analytical labs (including NABL-certified laboratories where applicable).
  • Global Dossier Preparation: CTD/ACTD submissions built for DPML and agencies such as US FDA, EMA, MHRA, TGA, GCC, SAHPRA, and others.

  🗺️ BA/BE Study Workflow for Côte d’Ivoire

  1. Feasibility & Gap Assessment: Review of reference product availability, dissolution method requirements, and biowaiver eligibility.

  2. Protocol Development: Drafting DPML-compliant BA/BE protocols and assisting with Ethics Committee approval.

  3. Analytical Method Development: LC-MS/MS method design and validation following ICH M10 and WHO TRS.

  4. Clinical Execution: GCP-based volunteer recruitment, dosing, sampling, and medical safety monitoring.

  5. Bioanalysis & PK Evaluation: PK modeling, QC verification, and statistical BE analysis.

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

  Who We Support

  • Pharmaceutical manufacturers in Côte d’Ivoire seeking DPML approval
  • CROs needing outsourced BA/BE or analytical support
  • Regulatory teams requiring DPML-compliant CTD/ACTD dossiersEnsuring Accuracy. Compliance. Regulatory Confidence for Côte d’Ivoire 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 Côte d’Ivoire regulatory requirements.

  We support pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, and exporters targeting Côte d’Ivoire with DPML-compliant analytical validation, ICH-aligned documentation, and complete post-submission handling of regulatory queries for product registration, marketing authorization, manufacturing/import approvals, and export dossiers.

  Our Core Expertise – Côte d’Ivoire Focus

  VALIDEX offers comprehensive preparation, review, and regulatory support for Analytical Method Validation as required by the Direction de la Pharmacie, du Médicament et des Laboratoires (DPML) under the Ministry of Health, Public Hygiene and Universal Health Coverage, Republic of Côte d’Ivoire.

  ✅ Assay Method Validation

  • Potency and content determination
  • Validation as per ICH Q2 (R1 / R2) accepted by DPML Côte d’Ivoire
  • 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 DPML & 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 DPML product registration and post-approval variation requirements

  ✅ Residual Solvents Method Validation

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

  Products Covered – Côte d’Ivoire

  ✅ 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 – Côte d’Ivoire

  All Analytical Method Validation activities are conducted in accordance with:

  • ICH Q2 (R1 / R2)
  • DPML Drug Registration Guidelines & Technical Requirements
  • Côte d’Ivoire Public Health Code & Pharmaceutical Regulations
  • WHO Technical Report Series (TRS)
  • WHO-GMP Guidelines (recognized by DPML)
  • USP / BP / EP Pharmacopoeial Standards

  Post-Submission Regulatory Support – Côte d’Ivoire

  VALIDEX provides complete DPML query management, including:

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

  Why Choose VALIDEX for Côte d’Ivoire?

  ✔ Strong understanding of DPML regulatory expectations
  ✔ ICH-aligned, WHO-compliant documentation accepted in Côte d’Ivoire
  ✔ 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 – Côte d’Ivoire

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

  Industries We Serve in Côte d’Ivoire

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

  National & Export Support – Côte d’Ivoire

  VALIDEX supports Analytical Method Validation for:

  • Côte d’Ivoire domestic product registration (DPML)
  • Manufacturing and import authorization applications
  • Export dossiers prepared for DPML-regulated and WHO-referenced markets

  Partner with VALIDEX – Côte d’Ivoire

  Achieve DPML-ready analytical validation with confidence.
  From method validation to regulatory approvals, VALIDEX is your trusted scientific and regulatory partner for Côte d’Ivoire.