ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.
Navigating FDA Layoffs: How Policy Layoffs May Impact Generic Drug Development
Layoffs at the Office of Generic Drug Policy Could Slow Development—but Strategic Guidance Can Help Sponsors Stay on Track
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...
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...
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...
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...
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...
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...
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...
The QPPV: An Essential Guide to the Qualified Person Responsible for Pharmacovigilance
When submitting marketing authorisation applications (MAAs) in Europe, the applicant (Marketing Authorization Holder, MAH) shall already have set up a pharmacovigilance system. A Summary of the...
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...
