Understanding the Different Types of Gap Analysis in Life Sciences
Discover the types of gap analysis in life sciences and how Facet Life Sciences can help address regulatory, clinical, and development gaps.
Importance of Asset Valuation in Pharmaceutical Research and Development
by Randy Goodman, PhDAsset valuation activities play a crucial role [...]
Identifying and Closing Gaps Before NDA Filing
Submitting a New Drug Application (NDA) is one of [...]
Three Key Considerations for Navigating FDA Oversight in Radiopharmaceutical Product Development
Radiopharmaceuticals present a distinct set of development and regulatory challenges. [...]
Navigating the CMC Journey in Radiopharmaceuticals
Insights from the “Tinker to Treasure” WebinarThe development of radiopharmaceuticals [...]
Behind the Scenes of an FDA Type C Meeting: A Case Study in Using Gap Analysis to Align Nonclinical Strategy in a Rare Pediatric Disease
By Tom Hallam, Ph.D., MBAFor small pharma companies navigating the [...]
Why Strategic Statistical Consulting is Essential & The Role of a Statistician in FDA Meetings
When preparing for a meeting with the FDA, most [...]
How Do I Determine Good Regulatory Guidance?
by Lisa Jenkins VanLuvanee, Ph.D.For small biotech and medical device [...]
Everyone is Talking About HEOR! What Exactly is it and Why is it Relevant to You?
By Dr. Randy Goodman Ph.D., MHA, FACHE, PMP, BCMAS [...]
Leveraging Breakthrough Therapy Designation (BTD) for Gene Therapy Development: Key Lessons from a Case Study
by Dr. Jason Mercer, Ph.D., RAC and Strategic Program [...]
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