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.
- Safety Report Case Processing (ICSR Management)
If your organization needs full service case processing or unique aspects of case processing, PharmaLex offers the full range of case processing services from collection, database entry, coding and medical assessment to regulatory submission customized to your requirements. We can operate within your pharmacovigilance database, or provide you with a complete case processing solution that includes a validated, E2B_R3compatible safety database.
- Ongoing monitoring and signal managementOur experienced experts will provide monitoring of the safety data for safety signals for your products . Upon detection, we will ensure signal validation, prioritization and assessment, and work with you to define and implement corresponding actions.
- Literature surveillance servicesOur Vigilit® system is an environment that meets all the legal obligations for literature surveillance. After setting up search criteria , in consultation with you, Pharmalex trained healthcare staff monitor the safety literature (global and local ) for your product. All findings are documented and processed according to requirements as agreed upon in a customized Literature Review Plan.
- Risk managementUtilize the PharmaLex team of experts to support you with the risk assessment for your product and the development and preparation of the Risk Management Plan/REMs. Our team will provide expertise in development and implementation of risk minimization measures and with measuring the effectiveness of your risk minimization plan. With experts in Europe and the United States, we are able to provide comprehensive global assistance.
- Aggregate Safety ReportsFree 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 agreementsDo 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 systems, audit and inspection supportPharmaLex can assist you 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. To prepare you for the likely situation of a PV inspection by regulatory authorities, PharmaLex can assist by training your employees, conducting mock inspections, or support your team onsite to ensure the best possible inspection outcome.
- EU-QPPV/local QPPV PharmaLex provides EU Qualified Person Responsible for Pharmacovigilance services to meet the EMA requirements to ensure safety oversight and regulatory contact for your organization. Additionally, PharmaLex provides deputy QPPV and local QPPV services in many countries.