Case Studies
Curated Regulatory Intelligence Augmented by AI
Pharma and Biotech
FDA Guidance on Developing Chimeric Antigen Receptor (CAR) T Cell Products …
The FDA’s latest guidance outlines crucial considerations for developing Chimeric Antigen Receptor (CAR) T cell products. Focused on safety, manufacturing, and clinical study design, this guidance addresses the complexity of gene therapy products. It emphasizes the need...
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Pharma and Biotech
Pharma Giant Leveraged RegASK to Proactively Monitor Regulatory Changes
The usage of dietary supplements and herbal medicine products continues to rise in several countries. However, the context of their usage varies widely across countries. While some restrict supplement use to general health and well-being, others allow...
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Pharma and Biotech
Boosting Claims for a Health Product Launch
Read the case study and learn how a major healthcare company successfully optimized their product launch and boosted claims to make it more compelling to consumers. Objective A major healthcare company wanted to validate its regulatory strategy...
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Pharma and Biotech
Driving Pharmaceutical Regulatory Intelligence for Better Decision Making
Results The company gained increased visibility into the regulatory landscape impacting their product categories, along with enhanced agility and confidence in risk management and decision-making processes based on industry trends and foresight. Book a demo to learn...
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Pharma and Biotech
Anticipating Regulatory Risks and Opportunities in Consumer Health Industry
Read the case study and learn from this practical example how to anticipate regulatory risks and opportunities in the consumer health and dietary supplements industry using RegASK’s cutting-edge technology tool. Challenge The client, a leading consumer health...
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Pharma and Biotech
Decentralized Clinical Trials: How CROs can benefit from our RegGuides
As the COVID-19 pandemic continues to disrupt clinical research, there is an increased need from the pharmaceutical and CRO industry to implement decentralized or hybrid clinical trials (DCTs) for improving clinical trial efficiency. Read our case study...
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Pharma and Biotech
How Real-World Evidence Supported Claim Substantiation on OTC Product in Eu…
A leader in the pharmaceutical industry wanted to leverage real-world evidence to bolster the claims of an over the counter (OTC) product in the E.U. and U.S. markets. Indeed, as researchers collect real-world evidence, they can examine...
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Pharma and Biotech
Market Entry to Mexico for a Health Product
Demand: Evaluating the Likelihood of Product Certification in the Mexican Market A large Chinese health-products company sought expansion into the Mexican market. The company requested RegASK’s assistance in determining the feasibility of gaining market entry into...
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