🇱🇷 Bioavailability & Bioequivalence (BA/BE) Studies Services for Liberia
LMHRA / ECOWAS-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt. Ltd., provides full-spectrum Bioavailability/Bioequivalence (BA/BE) study services and Comparative Dissolution Profiling (CDP) designed for the regulatory requirements of Liberia’s LMHRA (Liberia Medicines and Health Products Regulatory Authority).
Our studies follow ECOWAS Harmonized Medicines Regulations, WHO TRS, ICH, GCP, and GLP, supporting pharmaceutical companies seeking registration in Liberia and across the West African region.
💊 Core Services for Liberia (LMHRA / ECOWAS)
1. Clinical BA/BE Studies (Human)
Study Designs: Single-dose & multiple-dose; crossover or parallel study types accepted by LMHRA & ECOWAS.
Volunteer Selection: Healthy volunteers recruited under strict GCP standards.
Ethics Approval: Required from recognized Liberian Institutional Review Boards (IRBs).
Protocol Standards: Aligned with ICH E6 (R2), WHO BA/BE guidelines, and ECOWAS harmonized procedure.
2. Comparative Dissolution Profiling (CDP)
Requirement: Mandatory for generic drug submissions and formulation updates.
Media: Biorelevant and pharmacopoeial dissolution media.
Similarity Factors: f2 calculation, kinetic modeling, and statistical comparison.
Format: CDP presented according to CTD Module 3 requirements for LMHRA.
3. IVIVC & Biowaiver Support
BCS Biowaiver: Prepared following WHO, ICH Q6A, and ECOWAS biopharmaceutics guidance.
IVIVC Models: Level A, B, and C correlations.
Predictive Assessment: PK–dissolution relationship evaluation to support waiver requests.
4. Analytical Method Development & Validation
Technologies: LC-MS/MS and HPLC-UV for accurate bioanalysis.
Validation Approach: Fully aligned with ICH M10 and WHO analytical validation principles.
Stability Methods: API and product stability-indicating methods for ECOWAS dossier submissions.
5. Pharmacokinetic (PK) & Bioequivalence Statistics
PK Modeling: Non-compartmental PK analysis (NCA).
BE Evaluation: CI-based evaluation for AUC/Cmax using WHO/ECOWAS criteria.
Sample Size: Power-based calculation based on intra-subject variability.
📑 Liberia (LMHRA)–Ready Regulatory Documentation
We prepare complete CTD/ECOWAS-compliant dossiers suitable for LMHRA submission:
Clinical Study Protocol
Informed Consent Forms (English)
Investigator’s Brochure
Clinical Study Report (CSR) following WHO/ECOWAS CTD
Bioanalytical Method Validation Report
Comparative Dissolution Profile Report
CTD/ACTD Modules (1–5) for LMHRA submission
Required LMHRA/ECOWAS application templates
✨ Why Choose BioEquiGlobal for Liberia?
Regional Expertise: Understanding of LMHRA requirements and the ECOWAS Harmonized Medicines Registration System.
International Quality Compliance: GCP, GLP, ICH, and WHO-aligned operations.
Validated Infrastructure: Access to accredited analytical labs and clinical research units.
Pan-West Africa Support: Ability to prepare dossiers for Liberia, Sierra Leone, Guinea, Ghana, Nigeria, Côte d’Ivoire, Senegal, and other ECOWAS markets.
Global Dossier Readiness: Capability to prepare FDA, EMA, GCC, and India submissions alongside ECOWAS dossiers.
🗺️ Our BA/BE Workflow for Liberia
1. Feasibility & ECOWAS Requirements Review
Assessment of reference product availability, BCS classification, and LMHRA submission needs.
2. Protocol Development & Ethics Approval
Preparation of a study protocol aligned with WHO/ICH and obtaining IRB approval within Liberia.
3. Analytical Method Development & Validation
ICH M10–compliant LC-MS/MS method validation for bioanalytical testing.
4. Clinical Study Execution
Volunteer recruitment, dosing, sample handling, and medical monitoring per ICH-GCP.
5. Bioanalysis, PK & BE Evaluation
Bioanalytical data processing, PK computation, and BE statistical analysis.
6. Documentation & LMHRA Submission Package
CSR finalization, CDP reporting, and CTD module assembly ready for LMHRA.
Who We Support in Liberia & West Africa
Pharmaceutical manufacturers registering generics with LMHRA.
Regional companies seeking ECOWAS multi-country approvals.
CROs outsourcing bioanalytical or clinical BA/BE studies.
Regulatory teams preparing CTD/ACTD dossiers.