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.
Regulatory Sciences
Recently, the FDA updated a long-standing, decades old guidance on analytical test method validation based on revisions of the ICH Q2(R2) guidelines. Traditional test method validation requirements...
Regulatory Sciences
Having a highly efficient well-oiled Promotional Review Committee (PRC) machine is not just about having rock star reviewers and effective best practices in place. Although those are both critical...
Digital Transformation
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
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
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
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
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
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...
Digital Transformation
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
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
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...
Quality & Compliance
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...
Pharmacovigilance
Periodic Safety Update Reports (PSURs) play a pivotal role in ensuring the ongoing safety and efficacy of medicinal products once they've entered the market. While initial clinical trials provide...
Quality & Compliance
The Challenge: CAGT Treatments Require Time and Lack Availability Persons diagnosed with life threatening diseases which are now treatable with cell and gene therapies (CAGT) often needed to wait for...
Medical Information
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...
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...
The FDA’s homepage contains an item in the Public Health Focus section from the Office of Communications entitled “Don’t Use Expired Medicine.” Given this mandate, I recall from many years ago the...
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 Importance of the eCTD To harmonize the process of regulatory reviews for global drug development, a unified structure was developed and implemented for electronic Common Technical Document...
What’s Next for Rare Disease Innovation? For children suffering from rare and often life-threatening diseases, access to new and effective treatments can mean the difference between life and death....