Industry Insights

  1. Back To Basics: 505(b)(2) FAQs Part 4: Regulatory Strategies – Pharmacokinetic Studies 8/27/2021

    As the 505(b)(2) expert, Premier Consulting is frequently asked questions about how to get a product approved via the 505(b)(2) regulatory pathway and if this pathway is appropriate. Here is the final installment in the four part series of frequently asked questions (FAQs)

  2. Are We Adequately Assessing U.S. Pharma Supply Chain Risks? 6/26/2020

    There are gaps in our country’s collective knowledge required to determine the severity of the current pandemic’s risk to our supply chain for drugs. Undoubtedly, these gaps will remain, leaving questions that need to be answered and will, hopefully, serve as a road map for legislators and advocates of the industry.

  3. How To Avoid Pharma's Top 5 FDA Form 483 Triggers 10/13/2021

    Explore the most commonly cited conditions that led to the issuance of Form 483s last year (summarized by the FDA's most recent 12-month inspection period) and tips for avoiding them.

  4. The High Potent Market And The Role Of A Specialist CDMO

    Safe handling of HPAPIs is complex and the associated regulatory requirements are growing. Discover how leveraging a CDMO can ensure treatments reach patients faster, safely, and cost-effectively.

  5. Optimizing End-To-End Contract Analytical Support For Cell And Gene Therapies 7/11/2024

    The development and production of CGTs presents unparalleled complexities. Learn how a partner with robust end-to-end services can help you overcome challenges at every step of the drug lifecycle.

  6. A Digital-First Approach To Bio/Pharma Manufacturing Operations 5/10/2023

    Features such as real-time data monitoring, cloud solutions, and process integration comprise a digital operational excellence approach that adds value. But successful deployment of these and other digital solutions requires careful, cross-functional collaboration across the full life cycle of the project.

  7. Gene Therapy Competitive Dynamics: Winner Takes All? 5/6/2022

    A one-time gene therapy treatment with the potential to cure patients could create a “winner takes all” dynamic, whereby second and later entrants for the same indication would have significantly smaller patient populations. The extent to this dynamic will occur will depend on how similar gene therapy treatments are considered by payers, KOLs, and physicians to be comparable.

  8. Overcoming The Demand Standoff: How To Help Speed Adoption Of Innovative Medical Technology 5/24/2021

    Despite new breakthrough technologies being cost-effective and easy to use, as well as helping patients avoid surgeries, rehabilitation, and opioid exposure, many patients won’t get the coverage they need to access it due to the peculiarities of the physician–insurer relationship. This article shares lessons learned with sam, ZetrOZ Systems' wearable sustained acoustic medicine technology.

  9. The Path To Commercialization For Wearable Drug Delivery Devices

    Explore the evolution of the wearable drug delivery market, including the route to commercialization and the challenges faced.

  10. Tablet Tooling Nutraceutical Products 7/25/2023

    How can you reduce tooling wear and problems caused by abrasive ingredients during your tablet manufacturing process?