R&D Technology
What is a LIMS, and How Do I Know if I Need One?
What is a LIMS? At first, a Laboratory Information Management System (LIMS) sounds like something that would be useful in any lab. Isn't the purpose of a lab to produce information, and shouldn’t...
Pharmacovigilance
Meet the Expert: David Lough
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
Pharmacovigilance
An Overview of the PSMF: Pharmacovigilance System Master File
What is a PSMF? The EU Pharmacovigilance System Master File (PSMF) is a legally required document created and maintained by a Marketing Authorisation Holder (MAH). Essentially, the document is a...
Pharmacovigilance
The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)
Introduction According to §63a of the German Medicinal Products Act (AMG), a pharmaceutical entrepreneur who places finished medicinal products on the market that are medicinal products within the...
Medical Information
The Role of Patient Support Services in the Evolving World of Cell & Gene Therapies (CAGTs)
Cell and Gene Therapies (CAGTs) represent a transformative step in medicine, offering unprecedented potential to treat and potentially cure diseases once deemed untreatable. However, the path to...
Pharmacovigilance
The LPPV Network: An Essential Guide to Local Person Responsible for Pharmacovigilance
Every marketing authorization holder (MAH) needs a pharmacovigilance system to guarantee the safety of its products. Within the EU a pharmacovigilance system is defined as a system used by an...
Regulatory Sciences
How to Successfully Prepare for the HTAR Implementation in the EU
Health technology developers (HTD) planning submission of a centralized Market Authorization Application (MAA) to the European Medicines Agency (EMA) should being preparing today for the...
R&D Technology
Honing Your Veeva Vault RIMS Environment for Peak Performance
Regulatory requirements are a formidable challenge for early stage biotechs and top pharma alike. As health authorities continually revise guidelines across diverse markets, companies are tasked with...
Pharmacovigilance
Meet the Expert: Thomas Chatzopoulos
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Quality & Compliance
A Guide to Solving Complex Life Sciences Challenges
Life sciences organizations are consistently inundated with decisions and challenges of varying scale. These can occur anywhere during the life sciences value chain, under any treatment modality...