Introducing EU Annex 1: Understanding the Newest Regulatory Requirements

whitePaper | March 28, 2023

About 70% of new chemical entities (NCEs) are highly insoluble.1 It’s a fact that troubles small biotechnology companies and other drug manufacturers. Indeed, insoluble drugs present a wide range of challenges during development and, if not addressed, can ultimately render drugs ineffective in patients.

whitePaper | January 23, 2023

Investments in biopharmaceutical (biopharma) research and development (R&D) continue to fuel innovation and shape the future of health. However, this year’s analysis demonstrates that despite impressive examples of innovative products the step-change in improved productivity seen in 2021 has not continued.

whitePaper | April 7, 2021

In less than a week, in the face of a pandemic, the pharmaceutical sales model changed forever. In-person healthcare provider (HCP) visits came to a screeching halt and brand marketers scrambled to find ways to educate and engage these providers remotely. While the pandemic may have taken us by surprise, we should acknowledge that, even before the pandemic, pharmaceutical sales teams faced significant challenges. One solution for these challenges is to engage HCPs – virtually.

whitePaper | July 11, 2022

The expansion in the development and manufacturing of highly potent active pharmaceutical ingredients (HPAPIs) and complex active pharmaceutical ingredients (APIs) has grown tremendously as demands in healthcare to bring newer therapies to market quicker increase.

whitePaper | December 13, 2022

Viral vectors are a critical part of the advanced therapies supply chain as they are used to introduce the gene of interest, whether that’s into a cell intended for therapeutic gene transfer or for direct viral-mediated gene transfer into the patient.

whitePaper | July 8, 2022

Particulates are ubiquitous in parenteral drug products and remain a concern throughout their development and production1–3. These particles must be monitored to satisfy.