Put your pharmacovigilance concerns in experienced hands. Whether you need an urgent solution for an unexpected problem or are seeking to outsource entire pharmacovigilance processes – our experienced experts will be there for you.
We offer the full range of case processing services from collection, database entry, coding and medical assessment to regulatory submission. Our drug safety specialists will take over single aspects or the entire case processing service. We can operate with your own pharmacovigilance database, or provide you with a complete case processing solution that includes a validated, E2B-compatible database.
Ongoing monitoring and signal management
Our experienced experts can take over continuous monitoring of the safety data associated with your product for safety signals. Upon detection, we will provide assistance with signal validation, prioritization and assessment, and work with you to define and implement corresponding actions.
Literature surveillance services
Our Vigilit® system is a quality-assured environment that accomplishes all the functions related to your legal obligations for literature surveillance. After setting up searches in consultation with you, we continuously monitor the safety literature for your product, process detected case reports in a CIOMS I or E2B-compatible format, and push them through to you. Other safety-relevant literature can also be provided or feed into our continuous monitoring services.
A multidisciplinary team of experts is available to support you with the risk assessment for your product and the development and preparation of the Risk Management Plan. We can support you in developing and implementing of additional risk minimization measures and with measuring the effectiveness of such measures. With experts in Europe and the United States, we are able to provide comprehensive global assistance.
Periodic safety update reports
Free up your internal company resources and make use of our experience in preparing safety reports according to applicable regulatory requirements such as Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and Periodic Adverse Drug Experience Reports (PADERs). We carefully prepare all reports to comply with all regulations and submission standards.
Safety data exchange agreements
Do you need assistance preparing safety data exchange agreements? Let us manage them for you. We can provide company-specific development, monitoring and maintenance of these documents for manufacturers and/or distributors.
Pharmacovigilance quality system, audit and inspection support
Especially given the increasing complexity of regulatory requirements, companies desire efficient and transparent systems which guarantee an optimum level of compliance. Therefore, we offer our help in setting-up or improving your quality system. Our team of experienced experts prepares or reviews your quality documentation (PSMF, SOPs etc.) conduct audits (internal process audits, affiliate or vendor audits) and assist you with the corrective action. For the likely situation of a PV inspection by regulatory authorities we can assist by training your employees, conduct of mock inspections, or support your team onsite to ensure the best possible inspection outcome.
EU-QPPV / local QPPV
If required, we can take on the tasks and responsibilities of the EU Qualified Person Responsible for Pharmacovigilance, or provide a deputy in times of absence or illness. We can also provide local QPPV services in many countries.