PSUR Central – Global PSUR & PBRER Services
ABREMA/EAC-Compliant BA/BE & Comparative Dissolution Profiling Services — By BioEquiGlobal
BioEquiGlobal, a scientific brand of Zoesoe Exports Pvt. Ltd., delivers complete Bioavailability/Bioequivalence (BA/BE) Study Services and Comparative Dissolution Profiling (CDP) tailored for the regulatory framework of Burundi’s National Medicines & Food Regulatory Authority (ABREMA).
Our studies follow EAC Harmonized Technical Guidelines, WHO TRS, ICH, GCP, and GLP, supporting pharmaceutical manufacturers seeking product registration in Burundi and across the East African Community.
💊 Core Services for Burundi (ABREMA/EAC) Regulatory Submissions
Clinical BA/BE Studies (Human)
Study Types: Single-dose or multiple-dose; crossover & parallel designs required by EAC BA/BE guidance.
Volunteer Selection: Healthy volunteers recruited in line with international GCP standards.
Ethics Approval: Mandatory approval from a Burundi-recognized Ethics Committee or an accredited regional IRB.
Protocol Standards: Developed according to EAC BA/BE guidelines, ICH E6 (R2), and ABREMA submission expectations.
Comparative Dissolution Profiling (CDP)
Regulatory Need: Required for generic drug submissions, formulation updates, and variations.
Dissolution Media: Biorelevant and standard pharmacopoeial media aligned with EAC recommendations.
Similarity Evaluation: f2 similarity factor, model-dependent and model-independent assessments.
Reporting: CDP prepared per EAC Common Technical Document (CTD) structure.
IVIVC & Biowaiver Support
BCS-Based Biowaiver: Developed according to WHO, ICH Q6A, and EAC harmonized BCS guidance.
IVIVC Modeling: Level A, B, and C IVIVC models.
Predictive Performance: PK–dissolution link evaluation suitable for justification in ABREMA reviews.
Analytical Method Development & Validation
Platforms: LC-MS/MS and HPLC-UV systems for robust bioanalysis.
Validation: As per ICH M10 and EAC analytical validation principles.
Stability Indicating Methods: For both APIs and finished products, suitable for EAC dossier submission.
Pharmacokinetic (PK) & Bioequivalence Statistics
PK Analysis: Non-compartmental analysis (NCA) using validated tools.
BE Statistics: ANOVA, confidence-interval evaluation, and statistical methods accepted by EAC.
Sample Size: Based on variability and BE power calculations per EAC guidance.
📑 Burundi (ABREMA) / EAC-Ready Regulatory Documentation
We prepare a complete documentation package compatible with Burundi’s ABREMA and the EAC Harmonized Medicines Registration system.
Includes:
Clinical Study Protocol
Informed Consent Forms (Kirundi/French/English if required)
Investigator’s Brochure
Clinical Study Report (CSR) as per EAC CTD format
Bioanalytical Method Validation Report
Comparative Dissolution Profile Report
EAC/CTD Modules 1–5 formatted for ABREMA submission
Supplementary ABREMA application forms for generics
✨ Why Choose BioEquiGlobal for Burundi?
Regulatory Expertise: Familiarity with ABREMA, EAC Harmonized Guidelines, and regional submission expectations.
Global Standards: Operations under GCP, GLP, ICH, and WHO frameworks.
Accredited Infrastructure: Access to certified analytical labs and clinical research units.
Regional Reach: Ability to prepare multi-country EAC dossiers covering Burundi, Kenya, Tanzania, Uganda, Rwanda, and South Sudan.
International Support: Dossier readiness for EMA, US FDA, GCC, India, and other markets.
🗺️ Our BA/BE Workflow for Burundi
1. Feasibility & EAC Gap Assessment
Evaluation of reference product suitability, regulatory pathway, and dossier requirements for ABREMA/EAC.
2. Protocol Development & Ethics Approval
Development of EAC-aligned protocols and obtaining ethics clearance from Burundi or EAC-authorized committees.
3. Analytical Method Development
LC-MS/MS method creation and ICH M10 validation.
4. Clinical Study Execution
Recruitment, dosing, sample handling, and safety monitoring under ICH-GCP compliance.
5. Bioanalysis, PK & BE Evaluation
Full bioanalytical testing, PK computation, and BE statistical evaluation.
6. Documentation & Submission Package
CSR preparation, CDP reporting, and CTD dossier assembly for submission to ABREMA.
Who We Support in Burundi & East Africa
Pharmaceutical manufacturers seeking product registration in Burundi.
Companies planning EAC region-wide submissions.
CROs requiring analytical or clinical outsourcing.
Regulatory teams assembling CTD/ACTD dossiers for East African countries.Scientific Compliance for Burundi’s Evolving Market: ABREMA | EAC | ICH | WHO
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for the pharmaceutical and medical product sectors in the Republic of Burundi.
Burundi is significantly strengthening its regulatory oversight through ABREMA (Autorité Burundaise de Régulation des Médicaments à Usage Humain et des Aliments), established in 2021. As of 2025, Burundi has entered a new regulatory phase with updated texts that mandate the registration of medical devices and enhance post-marketing surveillance. As a member of the East African Community (EAC), Burundi is moving toward full alignment with regional harmonized guidelines. Our services ensure that your safety dossiers meet the rigorous expectations of ABREMA while remaining consistent with EAC-MRH standards.
Who We Support in Burundi
We provide specialized pharmacovigilance expertise across Burundi’s essential healthcare sectors:
International Pharmaceutical Exporters: Managing PBRER cycles for products imported into Burundi, ensuring compliance with CTD-format registration and ABREMA's safety mandates.
EAC Regional Manufacturers: Supporting firms in the East African region with aggregate safety reporting that facilitates joint assessment procedures across member states.
Medical Device & Diagnostic Providers: Assisting with the mandatory 2025 registration and vigilance requirements for medical devices and other health technologies.
Local Authorized Representatives: Providing technical scientific bandwidth in French and English to support local agents in managing authority queries and signal detection.
Public Health & NGO Partners: Drafting safety summaries for essential medicines and vaccines distributed via national health programs.
Our PSUR & PBRER Services
Our scientific precision aligns with ABREMA’s mission to ensure the safety of all health products in Burundi:
EAC-Harmonized PBRER Preparation: Expert drafting in the ICH E2C (R2) format, synchronized with the EAC Medicines Regulatory Guidelines adopted by Burundi.
French-Language Documentation: Professional preparation and translation of safety dossiers into French, as required for official registration files in Burundi.
Benefit-Risk Synthesis: High-level medical evaluations that justify the safety profile of products within the Burundian clinical context for ABREMA reviewers.
Signal Detection & ADR Management: Utilizing scientific methodologies to assess adverse drug reactions (ADRs) reported to the National Pharmacovigilance Centre in Bujumbura.
Technical Gap Analysis: Pre-submission reviews to ensure safety dossiers meet the updated 2025 regulatory texts and EAC joint assessment criteria.
Why Pharma Leaders in Burundi Choose PSUR Central
"Scientific rigor for Burundi’s modernizing and EAC-integrated healthcare market."
ABREMA Specialist Expertise: We track the latest updates from the Burundi National Medicines Regulatory Authority, ensuring your dossiers reflect current national mandates.
EAC Regional Excellence: Our reports are designed for the EAC-MRH framework, facilitating faster approval through regional reliance and joint assessments.
Bilingual Technical Proficiency: We bridge the gap between global English standards and Burundi’s official French requirements for technical documentation.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Burundi Regulatory Texts (2025 Updates): The latest national laws governing medicines and medical device registration.
EAC Harmonized Guidelines on Pharmacovigilance: The regional standard for safety monitoring across East Africa.
WHO Good Pharmacovigilance Practices: The global benchmark used by ABREMA to strengthen its regulatory functions.
ICH E2C (R2): The international gold standard for periodic benefit-risk reporting.
Get Started: Partner With Us
To initiate a customized project for your operations in Burundi, we typically require:
Product Portfolio and registration status (National or EAC Joint Assessment).
Approved Labeling: The SmPC (Summary of Product Characteristics) and Patient Leaflet in French.
Estimated Patient Exposure: Units sold or patient-years (Global and Burundi-specific).
Summary of ICSRs: Line listings and tabulations from your global safety database or local reports.
Submission Calendar: Coordination with your 9-to-18 month registration timeline or renewal cycles.
Contact PSUR Central today to ensure your pharmaceutical safety compliance in Burundi is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.