🇿🇦 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.
đź’Š 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