プロフィール詳細

プロジェクトを作成

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Dr. Béni W.に依頼

Congo, Republic of the

Pharmaceutical Regulatory Affairs Consultant | DRC & Central Africa Market Access Expert

プロフィール概要

As a registered Pharmacist and researcher specializing in pharmaceutical sciences, I bridge the gap between global pharmaceutical manufacturers and the Central African healthcare market. I specialize in Regulatory Affairs (RA) and market access for the Democratic Republic of Congo (DRC). ‎I assist international pharmaceutical companies in navigating the complex regulatory landscape of the DRC (ACOREP / Direction de la Pharmacie et du Médicament). From dossier compliance screening (CTD format) to strategic local partnerships, I ensure your products meet all local requirements for a smooth and compliant registration process. ‎My Core Expertise: ‎Regulatory strategy & Market Access for DRC and Central Africa. ‎Technical review and adaptation of registration dossiers (CTD/ACTD formats). ‎Post-marketing surveillance and local pharmaceutical marketing insights. ‎Liaison and project coordination with local authorized regulatory agents.

専門分野

• ☆ Industrial Engineering
• ☆ Manufacturing
• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Clinical Pharmacy
• ☆ Drug Discovery
• ☆ High Throughput Screening (HTS)
• ☆ Drug Target Identification
• ☆ Hit-to-Lead & Lead Optimization
• ☆ Phenotypic Assays
• ☆ High Content Screening/Imaging
• ☆ Medicinal Chemistry
• ☆ Drug Design
• ☆ Combinatorial Chemistry
• ☆ Structure-Activity Relationship (SAR) Studies
• ☆ Drug Development
• ☆ Drug Formulation
• ☆ Small Molecule Drug Development
• ☆ Biologic & Biosimilar Development
• ☆ Drug Substance Characterization
• ☆ Biosafety Testing
• ☆ Microbiology Testing
• ☆ Solid Form Screening
• ☆ Bioanalytical Testing
• ☆ Drug Stability Testing
• ☆ Preclinical ADME/PK/PD
• ☆ Drug-Drug Interactions
• ☆ Preclinical Research
• ☆ Pharmacogenomics
• ☆ Preclinical Pharmacology
• ☆ In vitro Preclinical Toxciology
• ☆ In vivo Preclinical Toxicology
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Drug Efficacy Testing
• ☆ Antibiotic Development
• ☆ Bioavailability
• ☆ Vaccine Development
• ☆ Clinical Trials
• ☆ Regulatory Affairs
• ☆ Immunotherapy
• ☆ Psychoactive Drugs
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Medical Law

サービス

• Consulting

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Digital Strategy Consulting, Healthcare Consulting, Legal Consulting, Operations Consulting, Scientific and Technical Consulting, Financial Consulting, Regulatory Consulting, Manufacturing Consulting

職務経験

Medical / Regulatory Affairs Representative

Gold Pharma Agency

9月 2025 - 現在

学歴

Doctor of Pharmacy (PharmD)

University of Kinshasa

9月 2018 - 9月 2024

認定資格

• Authentification certificate

  University of Kinshasa

  3月 2026 - 現在