Industry Insights

  1. Advantages Of No-Code Software Solutions For The Life Sciences 6/13/2023

    Learn how no-code solutions enable faster, less costly system implementation and validation, helping to reduce costs and timelines during the drug and medical device development and approval process.

  2. Using Synthesis And Route Design Technology To Approach API Complexity

    Leveraging computer-aided synthesis design technology and route scouting in the early stages of development can aid you in designing an efficient and cost-effective path to API manufacturing.

  3. Propelling Gene Therapies From Lab To Clinic

    Many companies are turning to CDMOs to optimize biomanufacturing processes and address the growing list of complications on the path to commercialization.

  4. Make This Your New EU IDMP Implementation Strategy 5/9/2022

    Just when the life sciences industry was as sure as it could be that EU Iteration 1 of ISO Identification of Medicinal Products (IDMP) implementation for centralized procedures in Europe was ready to go, the EMA announced a change of plan. Until further notice, the Digital Application Dataset Integration (DADI) user interface will be used to enable structured data submissions.

  5. 21 CFR Part 11: 7 Ways To Avoid Noncompliance 12/20/2022

    Explore the elements critical to 21 CFR Part 11 compliance, how they relate to noncompliance risks, and how a QMS software solution for life sciences simplifies the compliance process.

  6. How To Avoid Warning Letters For Data Integrity Nonconformances In Life Sciences 11/10/2022

    Data integrity is established where the data is stored and managed in its original form. Discover why the FDA expects manufacturers to ensure all data meets the guidelines outlined in the ALCOA acronym.

  7. The Influence Of Economic Factors On Biopharmaceutical Manufacturing 4/16/2025

    Understanding the complex effects of inflation, recession, and regulatory shifts is key to navigating the challenges faced by the biopharmaceutical manufacturing sector and ensuring its continued growth.

  8. Is It Ever Too Soon To Start Your Extractables And Leachables Assessment?

    Learn what you need to know about planning for your extractables and leachables testing programs to mitigate delays to your drug development timelines.

  9. PUPSIT As Part Of A Contamination Control Strategy (CCS) 8/21/2024

    Learn about the changes introduced in the latest revision to EU GMP Annex 1, and gain insight into the components that should be part of a PUPSIT risk assessment.

  10. Organ-Chips And Animal Models: Sensitivity Explained 3/8/2024

    Learn about the significance of sensitivity in drug development and how researchers can improve their pipelines by employing more sensitive models.