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.
If you work in a regulated industry, you’ve most likely heard the term eQMS or enterprise quality management system. But you may be wondering what is it? Why do I need it? And how do I choose the...
A recent survey showed that 33% of the organizations surveyed use paper quality management systems; 60% use some paper and some digital; and 7% use no QMS yet. (source: Gartner peer insights) Quality...
Regulatory Sciences
The FDA regularly issues new and revised product-specific guidances to facilitate the availability of generic drugs and assist the generic pharmaceutical industry with identifying the most...
Everything we do today is traceable. The integrity of the data, documents and decisions needs to be defendable and consistent. Electronic Quality Management Systems (eQMS) are an effective way to...
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...
Clinical Research Solutions
Do you really know how to accelerate the approval of your innovative product in Europe? The FDA's incentives for promising new medicines are widely known. Accelerated approval, priority review, fast...
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
Although not required, a Pre-IND Meeting is a critical milestone, one that is highly recommended by the FDA. The goal of the meeting is to receive general agreement from FDA that your drug...
Quality & Compliance
A drug must be safe and effective. Manufacturing of a drug product should consistently yield a predetermined quality. These are the undisputed goals for commercialization of a drug within our...
Regulatory Sciences
On Wednesday, September 29th, EMA announced the implementation of new measures indented to replace, reduce, and refine animal use in the development, manufacturing, and testing of human and...
Regulatory Sciences
Pharmaceutical companies spend massive amounts of money on drug development. Regardless of a firm’s size, the investment is substantial; the smallest error can have catastrophic consequences,...
Quality & Compliance
Are you always ready to be inspected for Data Integrity (DI) activities in your facility? Are compliance and data integrity aspects implemented in your organization’s QMS? Are the systems in your GxP...
Quality & Compliance
The corporate and quality culture has a significant effect on the maturity level of Data Integrity within a regulated company and should, therefore, be assessed and understood. To achieve the level...
Regulatory Sciences
Today’s patients benefit from having access to the safest, most advanced pharmaceutical systems around the world. This is because of the work done by the various regulatory bodies who govern the...
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...
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...