Latest Developments and Insights

Certain key strategies are imperative for establishing effective quality control (QC) systems in the development of new pharmaceuticals. The “Key 3” are implementing a QC process control strategy, creating a Standard Operating Procedure (SOP) manual, and partnering with experts.

One thing that we on the Technical and Quality Assurance (QA) QA team share with every employee throughout Syner-G is intelligence, passion, and unwavering commitment to making a difference. While every department within the organization brings unique knowledge and skill…

How AI and ML can facilitate quality improvements in biopharma Artificial Intelligence (AI) and Machine Learning (ML) are often confused, but they are fundamentally different. AI comprises pre-built products that use established patterns for recognition and decision-making, while ML predicts…

It’s imperative that biopharma organizations developing innovative treatments for rare diseases navigate the FDA’s Orphan Drug Designation (ODD) program. Since its passage in 1983, the Orphan Drug Act has helped countless individuals living with rare diseases receive access to life-saving…

May 4, 2022 | Nathaniel DiTommaso, MS, Regulatory Affairs Manager In May of 2014 and February of 2019, the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs…

January 10, 2022 | Julia DiFiore, PhD  |  Clinical Research Scientist Many of us involved with drug development derive a lot of satisfaction in knowing that our work contributes to improving the health of patients around the globe. We offer…