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.
Breaking the Chains of Project Management Dysfunction
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 new year.
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...
Four Benefits of Requesting an FDA Pre-IND Meeting
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...
Development with the End in Mind – Overcoming Early-Phase Challenges
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...
EMA Takes Steps to Minimize Animal Testing During Product Development
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...
Critical Issues in Drug Development: Don't Get Derailed in Developmental Efforts
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,...
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...
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...
How to Present Scientific Data That Generates Regulatory Approvals
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...
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...
Understanding Statistical Intervals: Part 2 - Prediction Intervals
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
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...
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
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...
Formal FDA Meetings for Sponsors or Applications of PDUFA Products
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...