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Clinical Research Solutions
New drug development is a costly, lengthy and risky process. Hurdles spring up at every stage and today's landscape puts sponsors under more pressure than ever before. Clinical trials are becoming...
Regulatory Sciences
The outbreak of COVID-19 (coronavirus) in the United States has significantly impacted our lives in virtually every way. For pharmaceutical and medical device firms, one of these impacts came on...
Each EU Health Authority has published a wide range of information regarding coronavirus, COVID-19, on their websites. In this blog we will continue to guide you through all these recommendations and...
Regulatory Sciences
Each EU Health Authority has published a wide range of information regarding coronavirus, COVID-19, on their websites. In this blog we will try to guide you through all these recommendations and...
Quality & Compliance
There is more to a project management office than managing projects. In fact, the project management office (PMO) acts as both a watchtower and a lighthouse to guide strategic initiatives toward...
Quality & Compliance
In the pharmaceutical industry today, there are strict guidelines to adhere to throughout the product lifecycle. Some of them, like risk management, seem more complex and harder to adhere to than...
ProPharma Group has launched a “Meet the Expert” series introducing you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to support...
Clinical Research Solutions
In the wake of the 21st Century Cures Act (December 2016), the FDA has switched gears to accelerate the development of novel therapies and speed up the review process, particularly in the field of...
Clinical Research Solutions
In May 2021, the new European regulations on medical devices (EU MDR) will take full effect. Organizations face a unique set of compliance challenges, mainly due to the numerous changes and additions...
Quality & Compliance
Reflecting on my interactions with FDA I have come to understand that inspectors do not routinely offer recommendations to firms, when an inspector does provide an opinion it is often prefaced with a...
ProPharma Group has launched a “Meet the Expert” series introducing you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to support...
Clinical Research Solutions
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...
Quality & Compliance
A common question when transferring an established process from one facility to another is how to establish that the transferred process is performing equivalently to the original process. Sounds...
Clinical Research Solutions
When applied rigorously and comprehensively, lean principles can reduce organizational costs while increasing productivity and strengthening the overall quality of submissions What is “Lean” as it...
Clinical Research Solutions
The research for cancer treatment is moving forward at a rapid pace. We're witnessing a shift from chemotherapy protocols to MTAs (molecularly targeted agents) for immunotherapies in particular....
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...
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....
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...
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...
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...