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.
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...
Imagine having your clinical trial ready to go, or already underway, and overnight the brakes are slammed, bringing your trial to a screeching halt. This was the reality for sponsors around the world...
In May 2022, the IVDD will be repealed by the European Committee, thereby ending the transition period. To ensure you're compliant with IVDR by that date, learn everything you need to know about the...
The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) offer various pathways that can expedite the development and review of new therapies to treat serious or...
Quality & Compliance
The compliance dates for the In Vitro Diagnostics Regulation (IVDR) are quickly approaching (May 2022). In this blog series, we discuss the final months before the IVDR date of application along with...
Maintaining compliance in the dynamic regulatory Chemistry, Manufacturing and Controls (CMC field can be quite a challenge. A CMC regulatory dossier compliance assessment is a critical component and...
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
What are Breakthrough Therapy Designation and PRIority MEdicines (PRIME) Applications? The advancement of modern medicine, and the accessibility of researched and regulated medication, has greatly...
Quality & Compliance
Roadmap for Successful IVDR Transition: The compliance dates for the In Vitro Diagnostics Regulation (IVDR) will become effective on May 26, 2022. To help you with the IVDD to IVDR transition, we've...
Quality & Compliance
With an increased need for high quality in vitro diagnostic medical devices (IVDs), the In Vitro Diagnostic Regulation (IVDR, 2017/746) was entered into force for all IVDs in 2017 with a five-year...
Although domestic travel is slowly ramping up, companies may still consider virtual factory acceptance testing (FAT). FAT is an optional step in the life sciences’ process of purchasing factory...
Clinical Research Solutions
Setting up a clinical trial in the European Union (EU) has historically been an expensive and time-consuming business. With 27 individual member states each requiring its own review and approval, it...
Clinical Research Solutions
Is it Time to Sharpen Your Target Product Profile (TPP)? We’ve heard it countless times: "Fail early and live to fight another day." "Preserve capital, human resources, and energy for a project with...
Quality & Compliance
Biostatisticians have become increasingly important as many data-driven public health projects and clinical trials have expanded. So, what exactly does a biostatistician do? These individuals are...
Clinical Research Solutions
One essential consideration in clinical trial development is whether the trial will represent a given population. The most representative trials use recruitment techniques and advanced statistical...
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...
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...
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....
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...
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...