Healthcare 2030 the consumer at the center

whitePaper | July 12, 2022

As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA ’s process validation (PV) guidance (1) and International Conference on Harmonization.

whitePaper | June 16, 2022

With increased scrutiny from regulatory agencies, advocacy groups and the public for clinical trial transparency, sponsors are feeling the pressure to ramp up efforts to make their studies more accessible

whitePaper | October 7, 2022

The Drug Supply Chain Security Act is one component of the DQSA. This particular act requires the FDA to implement a national track-and-trace system by which manufacturers must affix product identifiers (barcodes) to each package of product that is introduced into the supply chain.

whitePaper | June 22, 2022

The technologic and pharmacologic advances that have enabled researchers to take aim at previously untreatable diseases have contributed to an increase in the number of molecules in the development pipeline that are challenging and difficult to manufacture.

whitePaper | December 22, 2022

According to research, post-pandemic R&D growth is healthy in the pharma industry with the number of drugs in the R&D pipeline now exceeding 20,000 in 2022—which represents an expansion rate of 8.22% from 2021 (1).

whitePaper | December 14, 2022

When the regulatory hammer came down on pharmaceutical and life sciences (PLS) companies in the 2010s, it introduced new complexities for these businesses.