Expertise.
Pharmacovigilance.
We support you in comprehensively monitoring the safety of your medicinal products and meeting all regulatory requirements.
Secure?
Ensure the safety of your medicines through precise monitoring and rapid response to risks.
Efficient?
Optimize your pharmacovigilance processes for smooth and fast reporting.
Compliant?
Easily meet all global regulatory requirements and secure market access.
Pharmacovigilance Consulting.
Meet regulatory requirements and ensure the safe use of your products.
With the growing demands on drug safety, we support you in designing your pharmacovigilance systems efficiently and in compliance with regulations. Our in-depth expertise in regulatory requirements ensures that your monitoring processes meet the highest standards. Navigating complex regulatory requirements is challenging, but we offer customized solutions to meet all pharmacovigilance requirements and ensure the safe use of your products. In addition, we develop precise risk management strategies that identify and address potential safety issues at an early stage to keep your products safe and effective in the long term.
We support you with:
- Global pharmacovigilance strategy development: We develop individual strategies to efficiently fulfill global regulatory requirements.
- Optimization of pharmacovigilance processes: We analyze and improve your existing processes to ensure compliance and efficiency.
- Data management and quality assurance: We ensure the integrity and security of your pharmacovigilance data through validated systems and continuous quality controls.
Together we optimize your pharmacovigilance processes.
Our Pharmacovigilance Consulting Services at a glance.
Our pharmacovigilance services offer you comprehensive support in global drug safety, process optimization and quality assurance. We develop individual solutions that ensure your compliance and make your pharmacovigilance processes efficient.
Global strategy development.
- Development of customized strategies for compliance with international regulations
- Support in the creation of PSURs and RMPs
- Planning risk management strategies to minimize security risks
Optimization of processes.
- Analysis and optimization of existing processes for greater efficiency
- Implementation of CAPA measures to close compliance gaps
- Support in the preparation and implementation of audits
Data management and quality assurance.
- Implementation of efficient systems for monitoring side effects
- Validation of pharmacovigilance systems for maximum data integrity
- Ensuring compliance with regulatory requirements through continuous quality controls
Our success stories in Pharmacovigilance Consulting.
Find out how we have helped companies to optimize their pharmacovigilance processes and ensure drug safety.
Optimization of pharmacovigilance processes for a global pharmaceutical company
Side effect management for a biotechnology company
Implementation of pharmacovigilance technologies for a pharmaceutical company
Challenge.
A large pharmaceutical company faced the challenge of harmonizing its global pharmacovigilance processes and ensuring compliance with FDA and EMA regulations. Inefficient reporting structures and a lack of transparency in international data were jeopardizing compliance.
Measures.
- Implementation of a comprehensive pharmacovigilance consultation to improve global compliance.
- Introduction of a global pharmacovigilance system for real-time monitoring of safety data.
- Harmonization of processes for the submission of PSURs and risk management plans.
Results.
- Improved global compliance through standardized processes.
- 35% reduction in the time required to prepare and submit reports.
- 50 % increase in transparency in drug safety monitoring.
Success.
The company successfully harmonized its global pharmacovigilance processes and raised compliance standards.
Ready to take your pharmacovigilance to the next level?
Our pharmacovigilance service portfolio.
Our Pharmacovigilance Consulting Services help you to monitor the safety of your medicines globally, comply with the highest quality standards and efficiently fulfill regulatory requirements.
We qualify your suppliers and monitor MAHs, affiliates and specific audits of data and documents. Our internal audits ensure maximum compliance and process reliability.
We offer the provision of an EU QPPV and take over the outsourcing of pharmacovigilance quality assurance. We develop and review SOPs and guidelines to optimize your processes and ensure compliance.
Our experts define and implement CAPA measures and review risk management plans. We map your pharmacovigilance processes, identify optimization potential and strengthen your risk management.
We validate your pharmacovigilance systems such as Argus Safety or ArisG and plan data migrations including quality control. Our remote data entry support ensures efficient data management and high data integrity.
We develop e-learning content and provide training on pharmacovigilance processes and regulatory requirements. Our gap analyses of the quality system according to EU-GMP help you to close and continuously improve compliance gaps.
Ensure drug safety and global compliance.
Complementary solutions for your pharmacovigilance requirements.
Use our specialized services to further optimize the safety and monitoring of your products:
