Industry Insights

  1. Demystifying The Common Technical Document For Global Submissions 6/5/2025

    The CTD's Module 3 is notoriously complex and challenging. Here are strategies for an easier path toward CMC submission readiness.

  2. Integrated In Silico, Lab Assessments For Faster Drug Development 1/21/2026

    Integrated in‑silico and lab developability assessments flag molecular risks early, improving formulatability, manufacturability, and stability while reducing late‑stage failures, costs, and timelines.

  3. A Surprising Truth: CDMO Operations Should Be Boring 2/25/2026

    Operational excellence in drug manufacturing comes from predictability. Standardized, consistent processes reduce volatility and ensure steady, high‑quality progress.

  4. Design Success Combined With Expertise In Testing And Raw Material Selection

    Learn more about improvements and optimized benefits across the packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.

  5. Finding A Contract Manufacturing Partner That Fits 6/25/2015

    Any journey of discovery begins with the first step and so it goes when seeking manufacturing and contract services partners. The likely goal of course is to find partners that “fit,” but getting to whatever constitutes a “good” fit relative to your organization is a process that one should start with a bit of introspection; sort of like “you can’t have a good relationship with someone else until you know who you really are first.”

  6. What Drug Manufacturers Should Know About Operational Readiness 6/4/2025

    Moving beyond last-minute checklists, true Operational Readiness is about intentionally building success into your facility’s DNA. Discover the foundational elements that enable a smoother and safer startup.

  7. Is Pre-Compression Tablet Thickness A True Critical Operating Parameter? 2/12/2024

    As recently as Nov. 2023, the topic of how pre-compression tablet thickness is viewed raised its head once again in an FDA inspection at a generic pharmaceutical company in India. This control is available on all modern tablet presses, yet instructions for its use are vague. This article shares how to use this control correctly and to be better prepared for an agency inspection.

  8. Will FDA Finally Enforce DSCSA Interoperability In 2025? 12/26/2024

    Two experts weigh in on the persistent problems surrounding the Drug Supply Chain Security Act and its upcoming enforcement deadlines.

  9. Developing An Automated GxP Workflow Integrated With 21 CFR Part 11 1/22/2021

    The electronic records and electronic signatures (ERES) regulations, 21 CFR Part 11 and EU Annex 11, provide life sciences companies an opportunity to reap the organizational benefits of paperless record-keeping systems. 

  10. The Global Regulatory And Quality Environment For Biopharma Outsourcing 8/17/2020

    It is critical that organizations looking to engage an external contract service provider be aware of new regulations to align their programs with the latest expectations for each relevant market.