By Julie Rosenberg, MD Safety in drug development is critical, and a Pharmacovigilance (PV) consultant can help you with this vital work. PV consulting has emerged as a crucial service...
By Julie Rosenberg, MD Biotech and pharma industries move on tight timelines. This reality is made even more difficult due to complex and cross-border regulatory landscapes. Finding the right consultant...
Creating a blend of full-time and fractional resources in life sciences allows you to maximize your budget without compromising quality or missing deadlines. By LeeAnn Ali, BioBridges' SVP Development &...
The client was preparing to start a major submission for a marketing authorization in a rare disease and was faced with critical timelines and a complex development program. They needed their Clinical Submission Team Lead to be decisive yet adaptive during what was expected to be a challenging submission process.
As an established pharmaceutical company focused on neurological diseases was preparing for a submission and realized that they had not fully completed the necessary quality GMP and GCP activities during the course of the program.