Regulatory Articles

31. Reasons To Buy Into A Joint Auditing Program 5/26/2022

    Learn how you can save costs and time by having access to licensable joint audit reports.

32. Regulatory Convergence With Aurion Biotech 5/18/2022

    Advanced therapeutics are as complex as they are promising. Establishing a global regulatory strategy for these modalities requires a comprehensive, multifaceted approach.

33. Which Testing Does An Effective Certificate Of Analysis Include? 2/16/2022

    Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.

34. Method Transfer – When, Why, How? 2/16/2022

    A formal method transfer is an exercise that demonstrates and documents that a method has been successfully qualified in another laboratory to provide accurate and repeatable results.

35. 3 Ways To Survive The Shifts In Life Sciences 1/6/2021

    Over the past 20 years, the life sciences industry has undergone massive changes, and new software and partners have emerged. There are three key ways that business can serve the dynamic needs of modern drug development.

36. 3 Ways To Mitigate Data Manipulation Risk In Drug Development 1/6/2021

    A critical output of the drug development process, besides the compound itself, is data. We highlight specific actions to mitigate your organization’s risk of data manipulation and three key steps in tackling this problem.

37. Why Life Sciences Needs The Science Of Security 1/6/2021

    Given the complexities that arise when securing data in drug development and developing software that facilitates common workflows, ensuring best-of-breed security simultaneously is the key to success.

38. Surviving The Paperwork: Why Seamless Submissions And Good Compliance Envelopes Matter 12/10/2020

    Are you finding it increasingly challenging to manage your organization’s regulatory submission process? The entire process of developing a drug from preclinical research to marketing takes approximately 12 to 18 years and can cost billions of dollars before a drug is even approved. Learn how the advantages of a good ‘compliance envelope’ can far outweigh its costs by making companies operationally more effective, with a positive impact on the top line.

39. Top 5 Risks That Can Compromise Your Life Sciences Data 12/10/2020

    Keeping the clinical trial data secure and compliant is paramount. Restricting access to only those that need it is an essential first step, but there is much more that needs to be done. To help you in your journey, we’ve created a list of five common ways that trial data puts us in jeopardy, and approaches you can take to avoid these risks.

40. Ditch The Checklist: Why Automation Is The Key To Content Compliance 12/10/2020

    Checklists work for things like house maintenance; you identify and fix the things that don’t meet building codes, and then you feel safe, and the building inspector is happy. Content, however, doesn’t operate like that. Some content is essentially stateless; because of collaboration or continuously changing data, content assets change. Identifying adherence to compliance controls, therefore, means it has to be evaluated continuously. Automated, continuous monitoring is imperative for companies that depend on their critical content to make business decisions and conduct operations.