Successful pharmaceutical project onboarding – whether at a CRO, CMO or CDMO – hinges on three key factors: Flexibility Communication Relationships. All of these factors depend heavily on the project team. Select the Right Project Manager One of the most important elements of successful drug substance project onboarding is project […]

The objective of drug development is to successfully get a lead compound into clinical trials and ultimately to the patient population – as quickly as possible. Yet, just as important as speed is safety. In fact, if the applied analytical methods are not measuring the right parameters, speed-to-market becomes a […]

With Earth Day upon us, we are seeing a focus on how companies are trying to do their part to be environmentally friendly. Businesses worldwide are implementing green initiatives, and those initiatives may look quite different depending on the industry. In some sectors, going green means installing solar panels. In […]

Impurity control is a critical aspect of any pharmaceutical development process, but regulatory guidance tends to be vague where limited use during clinical trials is concerned. According to AstraZeneca’s Andrew Teasdale: “Permissible limits for impurities during clinical development has always been a grey area. Existing guidelines, specifically ICH Q3A, only […]

In the United States, a rare disease is defined as one that affects less than 200,000 patients. Today there are approximately 7,000 known rare diseases affecting more than 30 million Americans. Between 1973 and 1983, there were fewer than ten drugs on the market that treated rare diseases. In 1983 […]