EBEXCO
Consulting firm established in 2012 that provides regulatory and quality services for pharmaceuticals and medical devices, focusing on pharmacovigilance, medical device vigilance, GxP compliance and quality management system (QMS) implementation. The company offers globally distributed consultants and tailored programs to support regulatory submissions, inspection readiness, audits, SOP and QMS development, and safety surveillance.
Industries
Nr. of Employees
small (1-50)
Services
Comprehensive PV services including system implementation, ICSR processing, expedited reporting, PSUR/PBRER preparation, literature screening, PV audits and inspection support.
Design and maintenance of tailored quality management systems, custom SOPs and templates, GxP and QA audits, CAPA planning and training.
Incident evaluation, risk assessment, regulatory incident reporting, correspondence with competent authorities, and recall support.
Comprehensive PV services including system implementation, ICSR processing, expedited reporting, PSUR/PBRER preparation, literature screening, PV audits and inspection support.
Design and maintenance of tailored quality management systems, custom SOPs and templates, GxP and QA audits, CAPA planning and training.
Incident evaluation, risk assessment, regulatory incident reporting, correspondence with competent authorities, and recall support.
Expertise Areas
- Pharmacovigilance
- Medical device vigilance
- Quality management systems (QMS)
- GxP compliance
Key Technologies
- Pharmacovigilance databases and safety reporting systems
- Signal detection and literature screening methodologies
- Quality management system tools and documentation platforms
- Regulatory submission workflows
News & Updates
Discusses the role of adverse event handling, risk management and regulatory compliance in pharmacovigilance to improve medicine safety. Author: Lucas Ebert. Editor: Alex Fernandez.
Historical perspective on pharmacovigilance and the importance of extensive documentation and monitoring to ensure drug safety. Author: Lucas Ebert.
Discusses the role of adverse event handling, risk management and regulatory compliance in pharmacovigilance to improve medicine safety. Author: Lucas Ebert. Editor: Alex Fernandez.
Historical perspective on pharmacovigilance and the importance of extensive documentation and monitoring to ensure drug safety. Author: Lucas Ebert.