We support you in establishing a comprehensive and quality-controlled Pharmacovigilance System
Beyond merely fulfilling pharmacovigilance-related duties set out by legislation, Dr. Ebeling & Assoc. GmbH established strategies to implement US- and EU-tailored pharmacovigilance (PV) Systems at low cost that surpass inspection standards by authorities and audits by customers.
We offer special PV Systems for sponsors of generics:
- Integrating pharmacovigilance into an existing quality management systems or creating a time- and cost-effective quality management system for your specific needs
- Preparation of a Pharmacovigilance System Master File for US, EU, or global approaches
- Written procedures and SOPs facilitating the performance of quality-assured state-of-the-art pharmacovigilance
- Training for key personnel involved in pharmacovigilance activities
- Compliance monitoring of Key Process Indicators (KPIs)
- Risk-based auditing of contractual partners
Quality Management for PV
Increasing pharmaceutical globalization presents new challenges for generic companies in building and maintaining a global PV system that complies with national and international requirements and ensures a comprehensive system for drug safety.
We recommend solutions for pragmatic FDA-compliant PV/Quality management systems in terms of resource management, staff training, procedural documentation, quality control/monitoring/improvement and regulatory inspection preparation.
We help you meet FDA requirements and provide our expertise in handling inspections, and FDA-requests.
The Pharmacovigilance Reporting System
Key documents required for the PV System of a pharmaceutical company depends on interaction between PV and other (sometimes outsourced) departments. The quality management system and inter-departmental information exchange must facilitate the assessment, evaluation and improvement of PV-related activities. We support you in achieving PV goals while meeting US, EU, or global requirements.
PV Procedures and Services
We prepare written procedures for PV processes and related activities, thereby providing quality-assured solutions for critical components such as post-marketing surveillance:
- Signal management
- Literature monitoring
- Case processing and FDA-reporting
- PBRER/PSUR (periodic benefit-risk evaluation report)
- Risk Management Plans and REMS
- Originator compliance monitoring
- Safety measures and PIL/labeling reconciliation
- PV System maintenance
- Regulatory compliance assessment
- Synergy resulting from enhanced interactions between departments of your company
Medical Device Vigilance
Beyond our medicinal products expertise, we can provide services supporting your medical devices, such as a corresponding Vigilance System or Clinical Evaluations.
Dr. Ebeling & Assoc. GmbH is a Contract Service Organization (CSO) with experience in regulatory, quality and compliance consulting as well as in project and data management, providing a wide range of services in the areas of pharmacovigilance, medical device vigilance and medical writing for the Healthcare Industry.
By operating a flexible model for outsourced services, we enable our clients to better manage their costs and associated resources. Whether you need full-service pharmacovigilance solutions or project-specific consulting, our strategic concepts will be adapted to your needs.
In close cooperation with our US-office, we provide you with US- and EU-based expertise in planning a comprehensive pharmacovigilance strategy delivering quality-assured data on drug safety, which satisfies FDA on the one hand, and increases trust in generic products by consumers and healthcare providers on the other hand.
A beneficial situation for all involved stakeholders