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15 Days of Panic: You Received FDA Form 483 Warning Letter, Now What?
Remember the last time you were pulled over by the police? Maybe you had a taillight out. Perhaps you were speeding. You may have believed that you had done nothing wrong. Regardless of the specific situation, you probably panicked a little. It's human nature to panic when the law enforcement (or...
While Standard Operating Procedures (SOP’s) are widely and rightly used to control processes, there is sometimes a tendency within organizations to go “reference crazy”. In a well-meaning attempt to...
5 Steps for Developing and Managing Supplier Quality Programs
With the increased pressures of cost control for manufacturers of FDA-regulated products and the rapid expansion of globalization of the supply chain, the expectations of manufacturers and sponsors...
4 Key Parts to a Complete Product Complaint Handling Program
4 Key Parts to a Complete Product Complaint Handling ProgramAccording to 2012 FDA statistics, drug company’s Product Complaint handling systems (21 CFR 211.198) were cited in 142 Turbo EIR...
Blood Plasma, or simply plasma, is the liquid portion of blood. It has a number of vital functions in bleeding and infection control. It contains proteins and antibodies, which are produced by the...
Which Comes First, People or Systems? - Building & Maintaining Regulatory Compliance
Regulations require the pharmaceutical industry to be compliant, have and maintain a quality system, and build quality into the process (quality by design). What does that truly mean and how does the...
The Use of a Target Product Profile Early in Drug Development - A Great Program Management Tool
Let’s face it, drug development is a very long process. It is often hard for scientists in a laboratory to picture their drug actually being manufactured at large scale let alone to imagine it in a...
Project Management - 100% Responsibility and 0% Authority
Project Managers face a unique set of challenges every day. One of those that comes to mind often is how we, as Project Managers, succeed when we have 100% of the responsibility for the project...
Five Most Common Mistakes When Writing an Investigation
The most recent FDA report (FY2010) said the third highest reason a 483, warning letter, or consent decree was issued was because of discrepancies and/or failures in investigations due to inadequate...
Do you need a starting point for a Serialization User Requirement Spec (URS)?
One of the challenges to starting any User Requirement Specification (URS) is to envision a structure which can allow for traceability as the project continues. The attached sample URS is a starting...
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...
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...
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...
Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...
The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...
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...