🇿🇦 Bioavailability & Bioequivalence (BA/BE) Studies Services for South Africa

SAHPRA-Compliant BA/BE & Comparative Dissolution Profiling — By BioEquiGlobal

BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt Ltd, provides complete Bioavailability (BA), Bioequivalence (BE) studies, and Comparative Dissolution Profiling tailored to meet the SAHPRA (South African Health Products Regulatory Authority) requirements for generic medicines and post-approval variations.

Our workflows strictly follow:

• SAHPRA Guidelines for Bioequivalence (MRP & BE Requirements)

• WHO TRS Guidelines for BE (widely referenced by SAHPRA)

• ICH GCP & GLP Standards

• WHO & ICH Guidelines for Analytical Validation

• South African Clinical Trial Regulations

We support regulatory submissions for South Africa and global markets including USFDA, EMA, MHRA, TGA, Health Canada, and others.

💊 Core Services for SAHPRA Regulatory Submissions

Clinical BA/BE Studies (Human)

• Conducted per SAHPRA Bioequivalence Guidance and ICH GCP.
• Crossover & parallel BE study designs (single-dose & steady-state).
• Healthy volunteer & patient-based studies depending on therapeutic class.
• Ethics clearance through South African Human Research Ethics Committees (HRECs).
• Protocols designed as per WHO TRS, ICH E6 (R2), and SAHPRA regulatory expectations.

Comparative Dissolution Profiling (CDP)

• Required for BE justification, generic submissions, and post-approval variations.
• Dissolution studies conducted in USP/EP/Ph. Eur./WHO biorelevant media.
• f2 similarity factor calculation for profile matching (mandatory for SAHPRA).
• Both model-independent & model-dependent release kinetics evaluation.

IVIVC & Biowaiver Support

• BCS-based biowaiver justification according to SAHPRA, WHO TRS, and ICH guidelines.
• Level A/B/C IVIVC modeling for predictive dissolution–PK correlation.
• Supports waiver of in vivo BE for BCS Class I & III when appropriate.

Analytical Method Development & Validation

• LC-MS/MS and HPLC-UV analytical platforms used for drug quantification.
• Validation as per WHO/ICH M10 guidelines (accepted by SAHPRA).
• Stability-indicating methods for APIs and finished pharmaceutical products.

Pharmacokinetic (PK) & BE Statistical Analysis

• Non-compartmental PK analysis.
• BE evaluation using 90% CI acceptance range (80–125%) for key PK parameters.
• Sample-size calculation & power analysis per SAHPRA expectations.

📑 SAHPRA-Ready Regulatory Documentation

We prepare complete documentation for SAHPRA submissions, including:

• Clinical Trial Protocol (SAHPRA-aligned)
• Informed Consent Form (ICF)
• Investigator Brochure
• Clinical Study Report (CSR) compliant with SAHPRA & ICH E3
• Bioanalytical Method Validation Report
• Comparative Dissolution Profile (CDP) Report
• CTD Modules 1–5 for South African generic drug submissions

✨ Why Choose BioEquiGlobal for South Africa?

• SAHPRA-Focused Expertise: Thorough understanding of SAHPRA BE guidelines & dossier expectations.
• WHO-Aligned Approach: Many SAHPRA requirements follow WHO TRS — an area in which we specialize.
• Global Acceptability: Our studies meet international regulatory standards (USFDA, EMA, TGA, MHRA).
• Quality-Controlled Execution: GCP- and GLP-compliant clinical & analytical environments.
• End-to-End Support: From protocol design and dissolution comparison to PK/BE evaluation and CTD documentation.

🗺️ Our BA/BE Study Workflow for South Africa

1. Feasibility & SAHPRA Gap Assessment
   (Reference product evaluation, SAHPRA requirements review, biowaiver feasibility)

2. Protocol Development & Ethics Approval
   (Submission to South African HREC committees)

3. Analytical Method Development & Validation
   (LC-MS/MS validated as per ICH M10/WHO norms)

4. Clinical Study Execution
   (GCP-compliant dosing, PK sampling & safety monitoring)

5. Bioanalysis & PK/BE Evaluation
   (PK modeling, QC verification & BE statistical interpretation)

6. Final Documentation & CTD Submission
   (CSR, CDP report, validation package & SAHPRA-ready CTD)

Who We Support in South Africa

• Pharmaceutical manufacturers (oral solids, injectables, semisolids)
• API & formulation development companies
• CROs requiring BE/analytical outsourcing
• Regulatory teams preparing SAHPRA CTD dossiers
• Companies exporting to Africa, EU, GCC, USA & other regulated markets
• Innovators seeking comparative PK or reformulation studies