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Pharmacovigilance Services
Our skilled global team tailor-make solutions for any clinical and post-marketing pharmacovigilance (PV) obligations, compliant with EMA, FDA and ICH. We ensure that this is a comprehensive yet cost-effective process, enabling full compliance with legal requirements. We have a team of fully qualified medical professionals acting as QPPV’s with European, US or Global coverage.
We Provide
- A complete setup of a cutting-edge PV system with risk evaluation and mitigation programs
- A complete network of experienced resources (QPPV, Deputies QP, Medics) for your own PV activities within EU, US or Asia as registered Marketing Authorisation Holder.
- Data processing, guided by our PV specialists with over 10 years of experience, utilizing own software licenses of ORACLE ARGUS,
- Medical information and call centers services (24×7)
- Compilation of Aggregate Reports (PSUR/PADERs), RMPs, RMM, Core Safety Information, Signal Detection Reports
- Pharmacovigilance audits by certified PV auditors for US, EU as well as RoW
- Offering a team of PV auditors with extensive experience of global PV audits
- Complex support for any Medical-Legal Issues
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