Audits are valuable tools to diagnose problems and indispensable in a quality assurance system. Yäbulu performs independent, high quality standard pharmacovigilance audits to your company, affiliate or licensing partner.

Regulatory authorities are becoming increasingly active and demanding in their inspection activities. If you have been booked for a pharmacovigilance inspection or just want to be sure that your company is ready to undergo one, Yäbulu can prepare you.

It is an European requirement that a MAH has a QP for PV residing in the EEA. Additionally, Portuguese authority requires that MAHs with a MA in Portugal must have a local QP for PV residing in Portugal . If you have no need to assemble an office in Portugal or Europe , Yäbulu has qualified staff to fulfill the role of European or local QP for PV.

SOPs are a fundamental part of the pharmacovigilance systems. We are willing and able to write or review your pharmacovigilance SOPs, either locally, regionally or globally.

PSURs writing is time consuming. At Yäbulu we are experts at writing high quality PSURs. We can also simply review the PSURs you have written to ensure quality and consistency.

At Yäbulu we have wide experience at performing local and worldwide literature searches for information eligible for PSURs inclusion or just ICSRs.

We cover all stages of ICSR management: triage, data entry , quality control, medical review, submission and follow-up. We can take care of the whole process for you, or simply one or more of the mentioned steps.

Registering with the Eudravigilance allows your company to report electronically using the EVWeb tool. The EVWeb is free of charge and represents an economic way of fulfilling the requirement of electronic reporting for companies with a small number of ICSRs.

Yäbulu is prepared to train you and your employees in any aspect pertaining to pharmacovigilance.