🇨🇮 Bioavailability & Bioequivalence (BA/BE) Studies Services for 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 dossiers