INSIGHTS ON REGULATORY COMPLIANCE

• Closing The ‘Knowing-Doing’ Gap In R&D Using USP <1062> Data

  Data acquisition system tools have come a long way and now you can learn which trial runs will help you generate the most valuable data.

• MAM Solutions For Process, Product Control Of Biotherapeutic Proteins

  With industry-leading scientific expertise and customer support, we have pioneered solutions to some of the most pressing challenges facing customers interested in adopting MAM into their organizations.

• Data Integrity And Compliance In Bioanalysis

  Learn how a combination of controlled compliant workflow execution, dramatically streamlined data acquisition and an “audit by exception” approach offers the next phase of innovation within bioanalysis.

• A Guide To Pharmaceutical Quality Management

  Despite the inherent challenges of connecting quality and compliance data, there are tools that can help you to ensure quality's connectedness and central bearing. 

• 4 Digital Transformation Gaps In Pharmaceutical Manufacturing

  3/30/2023

  Take an in-depth look at the pitfalls of manual, paper-based manufacturing processes and why digitization could be the answer for pharma and medtech manufacturing of the future.

• The Write Side Of AI: Helping Hands, Not Replacement Plans

  3/1/2024

  AI applications in medical writing are in their infancy, and the technology suffers several shortcomings including plagiarism, copyright infringement, and misinformation dissemination.

• The Container Closure Integrity Requirements In The Revised EU Annex 1

  11/21/2022

  Learn about the advantages and disadvantages of CCI testing methods, how the revised EU Annex 1 may impact your strategy for ensuring CCI of sterile pharmaceutical products, and more.

• 10 Things To Know Before Writing An FDA 483 Response Letter

  7/6/2022

  Learn why time is of the essence when crafting a FDA response letter and remediation plan as well as the best practices for responding.

• Creating Accurate, Efficient, And Effective CDMO Project Proposals

  8/15/2023

  To receive the most comprehensive project proposal possible, it is important to fill out any questionnaire as accurately and completely as possible.