Industry Insights

31. Innovative Approach To Process Development 2/22/2021

    The key to successful development of safe, efficient, and cost-effective active pharmaceutical ingredient (API) production-scale processes is the application of smart chemistry and process development principles that include convergent strategies, telescoping, and open-mindedness.

32. Fast Track Designations For Your 505(b)(2) Drug Development Program 6/6/2022

    One FDA tenet is to get safe, effective drugs to market as soon as possible. Understand the details of Fast Track designation (FTD) and how 505(b)(2) products can qualify for this program.

33. Continued Process Verification: Driving Consistent Quality In Manufacturing 12/9/2024

    Continued process verification (CPV) ensures pharmaceutical processes remain controlled by monitoring key parameters, detecting variations, and maintaining product quality.

34. Fine-tuning Analytical Development Strategies For Every Phase 3/22/2024

    Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.

35. How To Select The Ideal HPAPI Manufacturing Partner

    To ensure the safety of personnel throughout the production of HPAPIs, manufacturers must effectively utilize containment and well-designed equipment.

36. The 5-Step Checklist For A More Mature, Robust Quality Management System 8/20/2021

    Whether you are preparing for a pre-approval inspection, have the corporate desire for continuous inspection readiness, or are engaged in a LEAN initiative to clean up and strengthen your quality management system (QMS), further maturing your QMS can be helpful to ensuring a robust, comprehensive, and compliant QMS.

37. Taking GMP Training From Painful To Practical 11/4/2015

    For many, GMP training is an event where attendees are herded into a room and are read the contents of the regulations or asked to watch a video. This video is often the same slides or video year after year.  Then, after this nice little break, everyone goes back to their jobs, forgetting about it until the next time the necessary evil called “GMP training” is required.

38. Partnering Through Membership For A Better Pharmaceutical Industry 11/7/2024

    Explore our series on key industry advocacy groups to learn how organizations like California Life Sciences (CLS) are driving innovation, fostering growth, and improving patient access in healthcare.

39. API In Capsule Vs. The Lost Art Of Formulation Development 11/5/2025

    API-in-capsule offers a fast path for early clinical data, but it can't eliminate the need for full formulation development. Weighing the potential for higher total development time and cost is critical.

40. Compelling, New Workplace Opportunities For Life Sciences Companies 9/29/2023

    In order to increase the likelihood of positive interactions across office teams and tenure, companies are building out more social spaces, focus nooks, and collaboration spaces for their employees.