🇿🇦 Bioavailability & Bioequivalence (BA/BE) Studies Services for South Africa
SAHPRA / SADC-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) aligned with the regulatory expectations of SAHPRA (South African Health Products Regulatory Authority).
All studies strictly follow SAHPRA Guideline 2.09, SADC BA/BE Guidelines, WHO TRS, ICH, GCP, and GLP, supporting pharmaceutical companies submitting generic medicines to South Africa and the broader Southern African Development Community (SADC) region.
💊 Core Services for South Africa (SAHPRA / SADC)
1. Clinical BA/BE Studies (Human)
Study Designs: Single-dose, multiple-dose; crossover & parallel designs as per SAHPRA 2.09 guideline.
Volunteer Selection: Healthy volunteers recruited under ICH-GCP requirements.
Ethics Approval: Mandatory approval from a South African Human Research Ethics Committee (HREC) registered with NHREC.
Study Protocol: Developed according to SAHPRA BA/BE guidelines, ICH E6 (R2), and WHO BA/BE recommendations.
2. Comparative Dissolution Profiling (CDP)
Regulatory Requirement: Essential for generic submissions, variations, and formulation bridging studies.
Dissolution Media: Biorelevant & pharmacopoeial media (USP/Ph.Eur./SADC).
Similarity Evaluation: f2 similarity factor; model-dependent & model-independent comparison approaches.
Documentation: Fully structured for SAHPRA CTD Module 3.
3. IVIVC & Biowaiver Support
BCS Biowaiver: Prepared per SAHPRA Biowaiver Guideline, WHO PQ, and ICH Q6A.
IVIVC Models: Level A, B & C correlation models.
Predictive Evaluation: PK–dissolution modeling for enhanced regulatory acceptability.
4. Analytical Method Development & Validation
Platforms: LC-MS/MS & HPLC-UV for precise quantification.
Validation: Conducted according to ICH M10 and SAHPRA bioanalytical validation expectations.
Stability Methods: Development of stability-indicating methods for APIs and finished products.
5. Pharmacokinetic (PK) & Bioequivalence Statistics
PK Analysis: Non-compartmental analysis (NCA).
Statistical Evaluation: CI-based BE analysis for AUC, Cmax per SAHPRA/SADC/ICH guidelines.
Sample Size Calculation: Power analysis adhering to SAHPRA’s statistical criteria.
📑 South Africa (SAHPRA)–Ready Regulatory Documentation
We prepare complete CTD-compliant regulatory documentation approved by SAHPRA, including:
Clinical Study Protocol
Informed Consent Forms (English + local languages as required)
Investigator’s Brochure
Clinical Study Report (CSR) in SAHPRA CTD format
Bioanalytical Method Validation Report
Comparative Dissolution Profiling Report
CTD/ACTD Modules (1–5) compiled for SAHPRA
Additional SAHPRA regulatory templates for generic product registration
✨ Why Choose BioEquiGlobal for the South African Market?
Regulatory Expertise: Proven understanding of SAHPRA’s strict requirements, timelines, and dossier expectations.
High Compliance: GCP, GLP, WHO, and ICH-driven operations ensure acceptance during regulatory review.
Advanced Infrastructure: Access to validated clinical units, bioanalytical labs, and audited partners.
Regional & International Capability: Support for submission across SADC, Africa, GCC, EU, US FDA, MHRA, and India.
End-to-End Services: From protocol design to dossier submission, all aligned to SAHPRA 2.09 BA/BE requirements.
🗺️ Our BA/BE Workflow for South Africa
1. Regulatory Feasibility & SAHPRA Gap Assessment
Evaluation of reference product, biowaiver eligibility, and SAHPRA-specific compliance needs.
2. Protocol Development & Ethics Approval
Preparation of ICH/WHO-compliant BA/BE protocol and securing HREC approval.
3. Analytical Method Development & Validation
ICH M10–validated LC-MS/MS method development, stability studies, and QC.
4. Clinical Study Execution
Volunteer recruitment, dosing, safety monitoring, and sample collection under strict GCP.
5. Bioanalysis, PK & BE Assessment
Bioanalytical phase, QC verification, PK modeling, and BE statistical comparison.
6. Documentation & Submission to SAHPRA
CSR, CDP, and CTD dossier preparation for regulatory submission.
Who We Support in South Africa & SADC
Manufacturers registering generic medicines with SAHPRA
Companies targeting SADC regional registrations (South Africa, Botswana, Namibia, Zimbabwe, Zambia, Malawi, Mozambique, Eswatini, Lesotho, Angola, Tanzania, DR Congo)
CROs outsourcing BA/BE clinical or analytical services
Regulatory teams preparing CTD dossiers for Southern Africa