The October 2022 updates to the Chapter 53 of the FDAs Post-marketing Adverse Drug Experience (PADE) Inspection Manual resulted in a few key changes. We’ve helped our clients prepare, oftentimes mobilizing not only within PV, but across cross-functional partners (ex. MedInfo, Quality, Marketing, Regulatory, & Legal). While PADE inspections build upon the successes (or shortcomings) … Read more
A Biotech is born. You’ve chosen the founding team and identified the therapeutic and disease model. You’ve also secured a preliminary investment round. Now it’s time to beat the odds by progressing through initial milestones towards commercialization. To make it to market, you must navigate the following: Funding Milestones Early Clinical Milestones First-In-Human (IND US-CTA … Read more
Consulting Magazine recognized SSI as one of the Top 10 Best Small Firms to Work For in 2021 and 2022. SSI Strategy offers clients consulting services to support the needs of the Medical Office including, Medical Affairs, Pharmacovigilance, and Clinical Development by combining business acumen and consulting discipline to service life science industry clients.