bio-regulatory-affairs-995x60

FEATURED ARTICLES

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  The Challenge Of Managing Regulatory Submissions & Correspondence

  Life science organizations produce large volumes of documents necessary for submitting applications to regulatory agencies. They need to have records of those documents as well as all related communications from sites around the world. This creates a situation that can be rather daunting.

  Sponsors must first make sure all documents are going through the proper review and approval cycle and that controls are in place to meet regulatory requirements such as 21 CFR part 11. Once the documents are published and ready for submission to the regulatory agency, they are typically stored on a file share. Although that file share has access controls in place, it will not have granular-level access controls.

• USP General Chapter <1207> Revisions: Industry Experts Offer Best Practices To Avoid Destructive, Unreliable Integrity Testing
• Getting Particular About Particulates: How Can You Avoid Becoming The Next Recall?
• Pilgrim Software's 10th Global Customer Conference Lauds 'Success Through Quality'
• The Plain Writing Act of 2010: Lessons for Industry

WEBINAR

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  Advancing Research In Skin Biology with Metabolomics

  This 30-minute webinar demonstrates how metabolomics can be a powerful tool in dermatological and skincare research.

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  Leveraging Metabolite Biomarkers For Clinical Trials

  This 30-minute webinar will introduce a robust, highly sensitive biomarker development program that leverages a revolutionary metabolomics discovery platform to improve the range of analytes that can be measured routinely and reliably.

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  Tapping The Metabolome For Answers- A State Of The Art Approach

  This 30-minute webinar provides a brief overview of recent advances in metabolomics technology and methodology, which together have advanced the field of metabolomics.

• Delivering Biologics With A Difference

  In this webinar you will learn about delivering intravenous-dosed biologics in an aseptically-filled intravenous bag and increase your understanding of the business drivers and potential value added with this strategy.