🇬🇳 Bioavailability & Bioequivalence (BA/BE) Studies Services for Guinea
ANSS / ECOWAS-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt. Ltd., provides complete Bioavailability/Bioequivalence (BA/BE) Study Services and Comparative Dissolution Profiling (CDP) tailored to the regulatory expectations of Guinea, governed by the ANSS (Agence Nationale de Sécurité Sanitaire).
All studies strictly follow ECOWAS Harmonized Medicines Guidelines, ICH, WHO TRS, GCP and GLP—supporting pharmaceutical manufacturers applying for product registration in Guinea and wider West Africa.
💊 Our Core Services for Guinea (ANSS / ECOWAS)
1. Clinical BA/BE Studies (Human)
Study Types: Single-dose & multiple-dose; crossover and parallel designs.
Volunteer Enrolment: Healthy volunteer studies following international GCP principles.
Ethics Approval: Review by an approved Guinean Ethics Committee or ECOWAS-recognized IRB.
Protocol Compliance: Prepared according to ICH E6 (R2), WHO BA/BE guidance, and ECOWAS dossier expectations.
2. Comparative Dissolution Profiling (CDP)
Requirement: Mandatory for generic drug submissions to ANSS.
Media: Biorelevant & pharmacopoeial dissolution media.
Analysis: f2 similarity factor, model-dependent & independent comparisons.
Reporting: ECOWAS-aligned CDP documentation suitable for CTD Module 3.
3. IVIVC & Biowaiver Support
BCS Biowaiver: Prepared per WHO, ICH Q6A, and ECOWAS regulatory harmonization.
IVIVC Models: Level A, B & C correlations.
Predictive Evaluation: Linking dissolution and PK profiles for regulatory justification.
4. Analytical Method Development & Validation
Platforms: LC-MS/MS and HPLC-UV.
Validation: Conducted according to ICH M10 and WHO validation principles.
Stability Methods: Stability-indicating methods for APIs & finished products.
5. Pharmacokinetic (PK) & BE Statistics
PK Modeling: Non-compartmental analysis (NCA).
BE Statistics: CI-based BE assessment per WHO/ECOWAS norms.
Sample Size & Power: Calculated based on variability and BE acceptance criteria.
📑 Guinea (ANSS)–Ready Regulatory Documentation
We prepare complete, submission-ready documentation for Guinea’s ANSS and ECOWAS Harmonized CTD formats:
Clinical Study Protocol
Informed Consent Forms (French/English as applicable)
Investigator’s Brochure
Clinical Study Report (CSR) according to ECOWAS/WHO CTD
Bioanalytical Method Validation Report
Comparative Dissolution Profile Report
CTD/ACTD Modules (1–5) adapted for Guinea
Required ANSS/ECOWAS application templates
✨ Why Choose BioEquiGlobal for the Guinea Market?
Regulatory Alignment: Expertise in ANSS requirements and ECOWAS harmonized dossier formats.
High-Quality Standards: GCP, GLP, ICH, and WHO compliance across all processes.
Advanced Infrastructure: Access to accredited clinical sites and validated analytical labs.
Regional Strength: Capability to support West Africa-wide submissions (Guinea, Senegal, Mali, Liberia, Sierra Leone, Côte d’Ivoire, Ghana, Nigeria, etc.).
Global Reach: Dossiers prepared simultaneously for US FDA, EMA, MHRA, TGA, GCC, and India.
🗺️ Our BA/BE Workflow for Guinea
1. Feasibility & Gap Assessment
Reference product verification, BCS screening, and ECOWAS requirement review.
2. Protocol Development & Ethics Clearance
Preparation of a compliant protocol and securing Ethics Committee approval in Guinea.
3. Analytical Method Development
ICH M10–validated LC-MS/MS method development for bioanalysis.
4. Clinical Study Execution
GCP-based study conduct, volunteer management, dosing & sampling supervision.
5. Bioanalysis, PK & BE Evaluation
Bioanalytical testing, PK modeling, and statistical BE evaluation.
6. Documentation & Submission to ANSS
CSR finalization, CDP preparation, and full CTD dossier assembly.
Who We Support in Guinea & West Africa
Pharmaceutical manufacturers registering generic drugs with ANSS.
Companies seeking ECOWAS multi-country regulatory approval.
CROs outsourcing BA/BE analytical or clinical phases.
Regulatory affairs teams preparing CTD/ACTD dossiers.