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.
Clinical Research Solutions
When conducting cleaning validation studies at large biologics or biotechnology facilities or perhaps even conducting a small cleaning validation study on a non-dedicated piece of equipment in the...
Clinical Research Solutions
No matter where I go I am always amazed at how many times the words calibration and verification are misused. I often hear statements like, “The instrument doesn’t need to be calibrated, the accuracy...
Clinical Research Solutions
The recently published request for comments regarding the Proposed Change to Rodent Carcinogenicity Testing of Pharmaceuticals signals intent by regulatory agencies to alter what Sponsors consider in...
Regulatory Sciences
On March 29, 2013, the FDA made available a draft guidance for Sponsors of biosimilar products outlining the procedures and processes for meetings with the FDA. Although much of guidance for the...
Quality & Compliance
Unexpected events often happen in the everyday world. However, in the regulated world great efforts are made to minimize the severity and frequency of unexpected events. Yet, despite best efforts,...
Clinical Research Solutions
“Cleaning, how hard can that be,” is the sentiment of those not in the bio/pharmaceutical industry. Even for those within the industry, the general consensus regarding Cleaning and Cleaning...
Clinical Research Solutions
FDA user fees have been a fact of life for regulated industries for nearly two decades. As you continue to comply by paying the fees, you should understand what the revenue does for you....
Clinical Research Solutions
Standardized prescription drug labeling was implemented by FDA in 1979. In the following years as labeling became more complex, FDA re-evaluated its usefulness and published a final rule in 2006...
Clinical Research Solutions
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...