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.
July 13, 2022
Developing, optimising, and manufacturing Advanced Therapy Medicinal Products (ATMP's), such as Cell and Gene Therapy (CGT) products is extremely complex. The choice of a reliable Contract...
June 6, 2019
You can expect several FDA audits throughout your drug development program The Agency’s goal is to protect the public from unsafe products, and one of the best ways to accomplish that goal is by...
December 4, 2018
Over the past 20 years, the traditional approach to drug development has expanded to include the outsourcing of a range of testing and manufacturing functions. As a part of their long-term strategic...
July 23, 2018
On Friday, July 13th, FDA announced the voluntary recall of several drugs containing the active ingredient valsartan. Valsartan is often used to treat serious medical conditions such as high blood...
November 6, 2017
On Tuesday, October 31st, the FDA announced that it will begin allowing eight European drug regulatory authorities to conduct inspections of manufacturing facilities and determine whether or not they...
June 28, 2017
On June 15, 2017, Hospira Inc. issued a voluntary recall of a number of its products after finding a microbial growth during a routine simulation of the manufacturing process, which represents the...
May 31, 2017
On Monday, May 22nd, the FDA issued a warning for drug manufacturers regarding the contamination risk posed by Burkholderia cepacia complex (BCC). According to FDA’s warning, “BCC and other...
May 2, 2017
The landscape of clinical trials is evolving. The changes that are happening are due to the increased number of FDA-regulated trials, as well as a rise in the complexity of clinical protocols. As...
February 15, 2017
In May 2016, the FDA inspected Resonance Laboratories Pvt. Ltd.’s Bangalore manufacturing facility. During this inspection, the FDA investigator observed a number of significant deviations from...