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
Background Developing medical devices (MDs), including in vitro diagnostic medical devices (IVDs), requires careful and result-oriented planning throughout the development process. One critical...
Regulatory Sciences
On October 31, 2024, FDA issued its final version of the ICH M13A guidance for industry, titled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”. This guideline provides...
Quality & Compliance
In the decades since the FDA first introduced Good Manufacturing Practice (GMP) regulations, the drug and device industry has undergone significant transformation. While the core principles of...
Medical Information
This fictional story illustrates how ProPharma can seamlessly support a REMS program to ensure patient safety, access to medication, and regulatory compliance. Through scenarios involving healthcare...
Digital Transformation
Science and technology are evolving rapidly, with an explosion in machine learning (ML) and artificial intelligence (AI) creating new possibilities for scientific discovery, operational efficiencies,...
Quality & Compliance
Right now, you are sitting in front of your computer and wondering how, based on current project status, you will achieve your remaining project goals for the year or achieve those planned for the...
Medical Information
Current Landscape of Medication and Healthcare Access in India India's healthcare system is a complex landscape with significant disparities in access to medical services and medications. Despite...
Medical Information
What is REMS? A Risk Evaluation and Mitigation Strategy (REMS) is a critical component of modern pharmaceutical regulation, designed to ensure that medications with serious safety risks are used...
Quality & Compliance
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...
Regulatory Sciences
A New Era for Pharmaceutical Development and Licensing in the UK The Windsor Framework, set to be implemented from January 1, 2025, marks a significant shift in the regulatory landscape for...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...
Quality & Compliance
In the world of pharmaceuticals, biotech, and medical devices, maintaining compliance with Good Practices (GxP) is critical to ensuring product safety, efficacy, and quality. But how do companies...
Pharmacovigilance
On January 31, 2022, the EU Clinical Trials Regulation 536/2014 (CTR) came into force with a transition period of three years. Now, as that transition period comes to a close, the process and need...
Quality & Compliance
The Nordic region, renowned for its world-class healthcare, presents unique opportunities and challenges for pharmaceutical companies. Understanding the Nordic pharmaceutical landscape is crucial for...
Full-Service CRO
Navigating the world of healthcare can be overwhelming, especially when it comes to affording medications. For uninsured or underinsured patients, Patient Assistance Programs (PAPs) may offer a...
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....