Industry Insights

  1. Combination Product QMS Requirements For The EU Market 6/30/2023

    Pharma companies are now building the capability to manufacture combination products in-house to increase flexibility and reduce dependency on third parties. This article shares key considerations for companies implementing a medical device QMS with regard to EU requirements.

  2. To CBT Or Not To CBT…It Shouldn't Be A Question 4/15/2015

    Recently, a colleague sent me a question about whether performance assessments as part of training – verification of a trainee’s ability to perform a task in accordance with predefined criteria – were an industry standard. 

  3. Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight 6/23/2025

    Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.

  4. Defining And Overcoming Batch Release Deviations 5/31/2024

    Agencies lack a specific definition for deviations, so it’s up to each company to clearly define what they are, and then build systems to prevent and react to them.

  5. A Semi-Continuous Operations Model For Solid-Dose Manufacturing 11/1/2017

    The estimated timeline for a drug product from discovery to market is 10 to 15 years. However, less than 12 percent of drug candidates that enter clinical trials will ultimately receive FDA approval. The Orphan Drugs Act of 1983 ensured that there were adequate incentives offered to drug developers working on therapies to treat fewer than 200,000 patients in U.S.

  6. Quality Assurance And Your CDMO 8/27/2019

    The result of regulatory compliance with quality standards is binary, but the processes employed to get there do not need to be rigid, inefficient, and expensive. Learn how innovation drives efficiencies.

  7. Super Generics: Market Trends In Europe 3/12/2024

    Super generics combine advanced formulations and delivery methods, and improved bioavailability, compared to traditional generics. This article shares market research trends in the market in Europe.

  8. Reducing Human Error In Pharmaceutical Manufacturing 10/5/2016

    Few experts would dispute that human error is the cause of most pharmaceutical manufacturing failures. Some estimate it to be as high as 80 percent.

  9. Implementing Green Chemistry In Biopharma: Design To Delivery 1/4/2023

    Applying a green strategy in drug development can reduce the number of synthetic conversions, shorten the linear synthetic route, and maximize the atom economy.

  10. Are You Approaching LIMS Validation Correctly? 4/26/2021

    Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.