Optimizing Preclinical Programs and Streamlining Clinical Translation

Optimizing Preclinical Programs and Streamlining Clinical Translation In today’s rapidly evolving pharmaceutical industry, successfully transitioning from non-clinical to clinical trials is a critical milestone for any drug development program. This process requires careful planning, strategic considerations, and a deep understanding of the challenges and opportunities inherent in this crucial phase. To shed light on this … Read more

Webinar: De-Risking Development: Strategies to Achieve Biotech Milestones

The Importance of Strategic Planning in Biotech Development Successful drug development in the biotech industry has never been more challenging. Companies face an increasingly risky funding landscape, intensifying regulatory requirements, and pressure to speed up timelines amidst resource constraints. However, early strategic planning can help mitigate risks and position programs for success. This was a … Read more

PADE Inspections: What You Need to Know & Why

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

SSI Strategy and NDA Group Announce Merger

SSI Strategy and NDA Group Announce merger, forming a best-in-class Global Life Sciences Consultancy   SSI Strategy and NDA Group are thrilled to announce the merger of our two organizations to form a premier consultancy company, specializing in guiding drug development companies from concept to commercialization.   The merger is an exciting next step, following years of … Read more