INSIGHTS ON REGULATORY COMPLIANCE

• Getting Your Investigational Drug Regulatory Ready

  Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.

• Top 5 Risks That Can Compromise Your Life Sciences Data

  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.

• IND Best Practices: 5 Tips For A Successful Filing

  There are many steps that need to be performed in order to assemble an Investigational New Drug (IND) Application. Whether it be consulting with the FDA, using a GxP compliant collaboration platform, or finding a partner, this process is often complex. Despite the numerous steps, it does not have to be an insurmountable goal. This webinar reviews 5 key best practices for assembling your IND and identifies specific tips that you can integrate into your workflow today.

• Using Egnyte For Life Sciences As GxP Repository

  Transitioning from the research phase to the clinical trial phase is a big step for any company, but it also means challenges, not the least of which means your electronic records need to comply with FDA 21 CFR Part 11 and GxP. In this democast, we will review how to deploy and use a GxP-compliant repository using Egnyte’s industry-focused platform, Egnyte for Life Sciences, without sacrificing usability or security, and without creating administrative overhead.

• Navigating Regulatory And Development Milestones

  This article addresses how early-stage biotherapeutic companies can avoid common pitfalls as they navigate the funding and regulatory processes to bring novel therapeutics from research to market.

• Automating Cell Therapy Manufacturing For GMP Compliance And Consistency

  Exploring the use of automation in cell therapy and advanced therapeutic medicinal product manufacturing to improve safety, quality, and compliance is a key factor in advancing patient care.

• Raman Spectroscopy Beyond The Lab: From Loading Dock To Production

  Raman spectroscopy offers a wide range of benefits in industrial and academic research, helping drive profitability in development, research, and quality control.

• Ditch The Checklist: Why Automation Is The Key To Content Compliance

  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.

• Container Closure Integrity Testing Of Sterile Injectable Product

  This article summarizes the current state of container closure integrity testing in the pharmaceutical and biopharmaceutical industries and outlines possible approaches for developing a CCIT strategy.