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.
Quality & Compliance
In this continuation from “Preparing for an FDA Inspection” I will discuss what I have witnessed as a typical outline of events for FDA inspections. Prior to setting foot at the facility, the FDA...
Full-Service CRO
The proper use of data science and predictive analytics can improve any online business, in or out of the medical field, but plays a particularly unique role in the life sciences. Science seeks truth...
Quality & Compliance
Europe consists of 44 countries, and 21 supranational organizations and within the EU alone there are 24 official languages. So, how do you navigate the differences across Europe in the EU? And more...
Reflecting on the 1937 Elixir of Sulfanilamide incident we can clearly appreciate the importance of clinical trials and monitoring patient safety today. For those that may not know, Sulfanilamide was...
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
In January 2020, FDA published a guidance document entitled “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient...
Quality & Compliance
The ultimate goal of the U.S. Food and Drug Administration is to protect the public welfare and protect consumers from unsafe products. Regulatory investigators are responsible for enforcing...
Regulatory Sciences
Recent recalls of dozens of lots of the front-line blood pressure and heart medications including valsartan, losartan, and irbesartan are placing the spotlight on impurities in generic drugs. After...
Quality & Compliance
The implementation of a robust Quality Management System (QMS) is a key success factor for clinical development with the goal of reaching marketing authorization. As important as your QMS is during...
Quality & Compliance
The involvement of Medical Monitoring (MM) and Data Safety Monitoring Boards (DSMB) in trials has been somewhat unknown to individuals outside of clinical circles. That is, until media attention...
Quality & Compliance
In early 2020, while COVID-19 was wreaking havoc on public health and safety, the FDA took the unprecedented step of postponing domestic and foreign inspections. The FDA’s risk-based inspection...
Quality & Compliance
Gene therapy holds the promise of curing severe genetic diseases at the genetic level rather than merely treating the symptoms as is accomplished using conventional small-molecule drug therapies. In...
The Food and Drug Administration (FDA) has laid out a drug development continuum that includes three milestones, or Type B meetings. Earliest is the Pre-IND meeting, the second is the End of Phase 2...
Regulatory Sciences
By the time the drug development process gets to Phase 3, it seems reasonable to assume that the chance of failure is relatively low. After all, the entire early-development process is at least...
Regulatory Sciences
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...
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 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...
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...