Drug Safety & Pharmacovigilance Services
Our drug safety philosophy is characterized by a dedication to ensuring that safety is not only with the drug but also the patients. Our Pharmacovigilance team provides extensive experience for end to end case processing of all types of safety events reported globally. With a mature global footprint, our safety team has the expertise and ability to manage safety events regardless of where they occur in the world, in a time-sensitive and regulatory-compliant manner.
A key aspect of safety management is the ability to ensure global regulatory compliance for submission of safety events per individual country regulatory requirements. Our safety team are experts in the field of safety submissions by providing regulatory intelligence and safety submission support through a safety submission portal with a dedicated safety submissions team. Our safety submission process ensures high compliance and the ability to ensure there is no over or under reporting of key safety events.
Drug Safety services for Phase I-III development include:
- End to end safety case processing for SAEs, AESIs or other safety events
- Safety report generation, distribution and submission through a submission portal
- Periodic and Annual safety report generation and submission
- Eudravigilance sponsor and product registration
- Responsible Person (RP) services
- Global regulatory intelligence
- Argus™ Safety Database
- Extensive experience working in client or 3rd party safety databases
- Adjudication oversight and management
- Safety Onboarding Academy
- Expertise in a variety of therapeutic areas such as oncology, CNS, and rare disease
We recognize the importance of ensuring the safety of your compound doesn’t end upon marketing approval. Our team can support you in the transition from pre-approval to approval of your compound ensuring the safety of your compound and transition is seamless.
Safety services for marketed products include:
- Serious and non-serious case processing and regulatory reporting
- Periodic safety update reports (PSUR), annual and quarterly report preparation
- Signal detection services
- Literature search services
- Argus™ safety database
- Registry, observational, phase IV and evidence
