Insights On Regulatory Compliance

  1. Modified Release Formulations: Extending Drug Commercial Lifecycle 3/1/2024

    A CDMO with expertise in modified-release dosage forms can provide valuable assistance in formulation development, processing considerations, analytical challenges, and regulatory requirements.

  2. What Is OPC Counting Efficiency? 6/24/2025

    Ensure cleanroom air quality with optical particle counters. Explore how OPCs work, their performance metrics, and key considerations for choosing the right one.

  3. Managing Complex Data In Process Development And CMC 11/12/2025

    Learn how automated platforms streamline data capture, integration, and analysis—enabling better decisions, improved consistency, and faster workflows across CMC and process development.

  4. Cell Culture Media Mixing In A Benchtop Single-Use Mixer 11/13/2025

    Explore how efficient powder-liquid mixing and sterile filtration preserve media integrity and support reproducibility in biopharmaceutical workflows, with promising scalability for larger-volume applications.

  5. Redefining Process Design And The Evolution Of Critical Process Parameters 8/6/2025

    Effectively managing process parameters and quality attributes is vital for successful drug development. Learn how a Quality by Design approach can optimize your processes and ensure product quality.

  6. Indian Biosimilar Companies Are Poised To Succeed In The Global Market 3/31/2025

    For Indian biosimilar developers looking to capitalize on the upcoming patent cliff, it is vital to play to your strengths and identify strategies for breaking into competitive regulatory markets.

  7. Closed Sampling: Crucial For Aseptic Processing 6/26/2025

    Explore the critical role of closed sampling in bioprocessing by gaining insight into regulatory frameworks, system integrity, and aseptic practices essential to ensure compliance and product quality.

  8. From Day One Success To Everyday Improvement: The OR → OE Continuum 11/24/2025

    Bridging the gap between initial startup and long-term sustainability requires a unified strategy. Learn to transform early readiness metrics into a durable operating system that drives continuous performance improvements.

  9. Top 3 Life Sciences Compliance Strategies Every Startup Needs 1/28/2025

    Life sciences startups must integrate compliance early to ensure regulatory approval, and trust. Prioritizing compliance streamlines processes, and enables long-term success in this highly regulated industry.

  10. Modernizing Compendial SEC Methods For Biotherapeutics 4/16/2024

    Explore the advantages of a bio-inert HPLC system through the migration and modernization of a compendial SEC method outlined in the United States Pharmacopeia (USP) General Chapter <129>.