Expertise.
QPPV.
Our QPPV services ensure drug safety and support you in complying with all regulatory requirements.
Compliant?
Does your company meet all regulatory pharmacovigilance requirements?
Efficient?
Are all safety reports submitted and evaluated on time?
Reliable?
Is the safety of your medicines continuously monitored and documented?
Ensure drug safety with our QPPV expertise.
QPPV - Ensuring drug safety and compliance.
Our QPPV services ensure that all regulatory requirements in the area of pharmacovigilance are met and that the safety of your medicines is continuously guaranteed.
As a Marketing Authorization Holder (MAH), you are required to designate a Qualified Person for Pharmacovigilance (QPPV) to ensure drug safety. Our QPPV services include continuous monitoring of the safety profiles of your products, timely submission of reports and communication with health authorities. We support you in meeting all regulatory requirements and minimize risks associated with your medicinal products.
Our services include:
- Continuous safety monitoring We monitor the safety data of your medicinal products and ensure that safety-relevant events are reported in good time.
- Regulatory reporting: Preparation and submission of PSURs and Risk Management Plans (RMPs) in accordance with legal requirements.
- Communication with authorities: Direct point of contact for health authorities to ensure that all regulatory requirements are met.
Qualified Person for Pharmacovigilance Services at a glance.
Our QPPV services offer comprehensive support in ensuring drug safety and compliance with regulatory requirements.
Continuous safety monitoring.
- Monitoring the safety profiles of your medicines
- Timely reporting of side effects and safety-relevant events
- Compliance with all pharmacovigilance requirements
Regulatory reporting.
- Creation and submission of PSURs and RMPs
- Support in preparing for audits and inspections
- Ensuring compliance with international regulations
Communication with authorities.
- Direct contact for health authorities
- Support with official audits and inspections
- Advice on adapting to new regulatory requirements
Our QPPV projects to ensure drug safety.
Find out how we have supported companies in optimizing their pharmacovigilance processes and ensuring drug safety.
Introduction of a comprehensive pharmacovigilance system for a pharmaceutical company
Optimization of pharmacovigilance processes for an international biotechnology company
Challenge.
An international biotechnology company needed support in optimizing its existing pharmacovigilance processes to ensure that they meet the requirements of global markets.
Measures.
- Revision and standardization of pharmacovigilance processes in accordance with the requirements of various markets
- Introduction of a global pharmacovigilance reporting system for better data processing and transmission
- Conducting training for the global team to implement the new processes
Results.
- Optimized and standardized pharmacovigilance processes worldwide
- Improved collaboration between the global teams
- Reduction in processing time for security-relevant reports
Success.
The company was able to successfully roll out its pharmacovigilance processes globally and ensure compliance with international regulations.
Use our QPPV services for maximum drug safety.
Our QPPV service portfolio.
With our QPPV services, we ensure drug safety and compliance with all regulatory requirements worldwide.
Our experts continuously monitor the safety data of your medicinal products and ensure that safety-relevant events are reported to the responsible health authorities in a timely manner.
We prepare and submit all required reports, such as PSURs and RMPs, on time. Our experts support you in preparing for audits and inspections and ensure that your reporting always complies with regulatory requirements.
We act as a direct point of contact for the health authorities and ensure transparent and timely communication. We also continuously monitor regulatory requirements and adapt your pharmacovigilance processes to new regulations.
We support you in preparing for regulatory audits and inspections to ensure that all processes and documentation comply with regulatory requirements. Our experts ensure that your pharmacovigilance activities meet the highest compliance standards.
Our experts optimize your internal pharmacovigilance processes to ensure drug safety and compliance with regulatory requirements. This includes the continuous improvement of processes for monitoring and reporting safety events.
We provide training and workshops for your team to ensure that everyone involved understands and can implement the pharmacovigilance requirements and the role of the QPPV. This strengthens compliance and improves internal efficiency in drug safety.
Ensure drug safety and meet all regulatory requirements.
Related topics for comprehensive drug safety.
These supplementary services support you in meeting all regulatory requirements in the area of drug safety:
