Regulatory Articles

1. FDA's New Flexible CMC Framework For CGT 4/14/2026

   The FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.

2. Flow Chemistry For Contemporary Isotope Labeling 1/26/2026

   Gain insight into how late‑stage exchange and flow‑based methods enable efficient access to labeled molecules for pharmaceuticals, mechanistic studies, and analytical applications.

3. Navigating The Regulatory Space To Biosimilar Approval 9/1/2025

   The biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence.

4. FDA Leading The Decline Of Animal Testing 7/16/2025

   The gold standard practice of conducting animal studies for evaluating toxicity, pharmacodynamics, and immunogenicity is being challenged by innovative alternatives – New Approach Methods (NAMs).

5. The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly 3/3/2025

   In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.

6. Revolutionizing Drug Discovery: The Rise Of Fashionable Models 6/6/2024

   As a result of advancements in research technology, "fashionable models" such as organoids and organs-on-chips (OoCs) have been developed. Explore organoid and OoC technologies in detail.

7. Emulate Endorses The FDA Modernization Act Of 2021 5/10/2024

   Learn why removing the mandate for animal testing would enable faster, more efficient, and more humane drug development, all while benefiting both patients and the pharmaceutical industry.

8. Developing A Comprehensive Regulatory Approach For LNP Drugs 2/26/2024

   The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.

9. Developing Injectable Drug Placebo Formulations For Clinical Trials 1/9/2024

   Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.

10. Transitioning From Research To Drug Formulation And Development 11/27/2023

    The transition from academic research and studies to industry research demands that individuals master additional skills, set different objectives, and define “success” differently.