Expertise.
Pharmacovigilance.
We support you in comprehensively monitoring the safety of your medicinal products and meeting all regulatory requirements.
Are you sure?
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.
Together we optimize your pharmacovigilance processes.
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.
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 pharmacovigilance 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 pharmacovigilance 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 pharmaceutical company needed to integrate modern technology into its pharmacovigilance processes to achieve global compliance and increase efficiency.
Measures.
- Introduction of a new pharmacovigilance software system to automate processes.
- Training staff in the use of the new technology.
- Adaptation of processes and documentation to international standards.
Results.
- Increase process speed and reduce manual errors.
- Fulfillment of compliance requirements in all target markets.
- Improved data quality and transparency.
Success.
The company strengthened its market position and ensured the safety of its medicines worldwide.
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.
