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.

REGULATORY COMPLIANCE SOLUTIONS

  • Daikyo Crystal Zenith®

    The Crystal Zenith (CZ) polymer addresses the need for a clear, biocompatible material that overcomes problems inherent in glass vials, syringes and cartridges. 

  • Aseptic Fill & Finish

    Timely delivery of high-quality investigational drug products is key for the success of your trial. Rely on your dedicated August Bioservices team for flexible, cost-effective solutions to your aseptic fill and finish needs. Our GMP manufacturing facility for preclinical and Phase I and II trial materials complies with FDA and EU regulations and includes 1,000 square feet of ISO 5-7 aseptic processing space.

  • Pharmaceutical Automation & Information Technology Services

    As a company that specializes in troubleshooting complex systems and equipment, especially in regulated industries, we have gained expertise in Automation & Information Technology (IT) systems. These systems are the foundation of the manufacturing equipment and processes we have been commissioning and qualifying for over 20 years. Our teams work to deliver fully functional and compliant, mechanical and automated systems to our clients. Our expertise extends from specification, through implementation and startup, and into true process optimization.

  • GxP Document Management For Life Sciences Guide

    Choosing the right document management platform comes with daunting responsibility: compliance, usability, and adoption to name a few. We created this Buyer’s Guide to provide you with a tangible framework to evaluate varied solutions and, ultimately, identify one or more that meet your specific use case.

  • Reduce Cost And Effort When Servicing Clinical Trials In Canada

    Contracting an in-country clinical depot helps bring costs and timelines under control.