by Nick | Mar 10, 2022 | Clinical Research, Pharmacovigilance, Regulatory Affairs
Like the rest of the world, the pharmaceutical and biotech industries are beginning to worry about their ability to continue operations. And, with good reason. Russia’s invasion of Ukraine affects millions of people, not just in this Eastern European nation but...
by Nick | Oct 25, 2021 | Pharmacovigilance, Regulatory Affairs
Whitepaper Regulatory Affairs Outsourcing Affiliate-Based Outsourcing for Regulatory Affairs acts as an addition or replacement of your in-house local regulatory capabilities. However, it frequently falls short of meeting the requirements for effective organization,...
by Kamile Gruduls | Jul 2, 2021 | Pharmacovigilance
During the last years, there has been a skyrocketing demand for pharmacovigilance as medicinal products consumption is growing and disorders and diseases are becoming more prevalent. To top this, an increasing number of adverse drug reactions (ADRs) is becoming a...
by Nick | Jul 1, 2021 | Pharmacovigilance
Setting Up a Pharmacovigilance System from Scratch In the EU/EEA, US, and other major pharmaceutical markets, you need a sound plan for post-market surveillance for your medicinal product’s Market Authorization Application (MAA). A robust pharmacovigilance (PV)...
by Kamile Gruduls | Jun 9, 2021 | Pharmacovigilance, Webinar
Webinar: Strategic Pharmacovigilance Activities. Scalable and Tailor-made Outsourcing Models Larger companies often limit their strategic pharmacovigilance activities outsourcing only to highly manual and repetitive tasks, while the smaller ones may want to outsource...
by Nick | Jun 1, 2021 | Pharmacovigilance
Advantages of QPPV Outsourcing in the EU/EEA Pharmaceutical companies with a primary base outside the EU, companies without in-house PV capabilities or companies with business decisions to refocus their workload on core strategic competencies often look to externalize...
