Discover how QbD Group's expert support enhanced a pharmaceutical company's pharmacovigilance, leading to a favorable inspection outcome by the local Regulatory Authority (AEMPS).
A Spanish generic pharmaceutical company, with 90 products currently on the market, reached out to us to outsource all their pharmacovigilance (PV) activities. Initially, we were approached by their Quality Department, and later the CEO got involved. They required a Quality PV but lacked the time to manage it themselves.
Our client faced significant challenges due to a previous negative experience managing pharmacovigilance (PV) internally. They lacked internal resources and time to effectively implement PV activities. Additionally, there was a notable lack of experience in fulfilling the EU Qualified Person for Pharmacovigilance (EU-QPPV) role.
QbD Group’s approach involved acting as the Responsible Person for Pharmacovigilance (EU-QPPV) and Deputy in front of Health Authorities. We maintained and updated the PSMF bi-annually and revised the client’s SOPs as needed. Our team conducted bibliographic searches and regulatory intelligence, managed suspected adverse reaction cases via the Vigilazierta database, and maintained the XeVMPD. We updated SDEAs, conducted third-party audits, and prepared comprehensive safety reports including PSURs, RMPs, ACOS, signal detection…
Additionally, we provided on-demand support for health authority responses, expert medical advice, audit and inspection assistance, and annual PV training.
Partnering with QbD Group for Pharmacovigilance (PV) activities led to a successful inspection outcome by the local Regulatory Authority (AEMPS). The effective project management provided by QbD Group instilled total confidence and peace of mind. Additionally, this partnership facilitated cross-selling across various QbD services, including the introduction of 10 new cosmetics under Cosmetovigilance and the implementation of a new Regulatory Affairs (RA) dictionary.
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