INSIGHTS ON REGULATORY COMPLIANCE

  • Advantages In The Continuous Manufacturing Of APIs And Intermediates Under cGMP Conditions
    11/11/2020

    When it comes to APIs and advanced intermediates, there are few pharmaceutical companies that have successfully utilized continuous manufacturing for more than a single process step. In addition, very few have been able to scale-up beyond the kilogram range under cGMP conditions. In this interview with Dr. Andreas Meudt, Head of Exclusive Synthesis for Evonik, the challenges and opportunities for the use of continuous manufacturing for APIs and intermediates are reviewed.

  • How To Ensure Chemical Inventory Safety And Compliance With Regulations
    4/21/2021

    When federal, state and local safety regulations regulations concern chemicals, it is vital that the organization deploy efficient processes and systems that enable laboratory and Environmental, Health and Safety (EHS) personnel to easily comply with the regulations, ensure safe chemical management and produce accurate chemical inventory reports. This white paper discusses the obstacles organizations face ensuring chemical compliance and how different organizations have solved the compliance challenge.

  • Achieving Business Continuity In Pharma During COVID-19 Restrictions
    3/4/2021

    To ensure business continuity during COVID-19 restrictions, we developed a virtual factory acceptance testing solution that allowed SaudiVax to advance their manufacturing plan.

  • Automating Cell Therapy Manufacturing For GMP Compliance And Consistency
    11/1/2019

    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.

  • Upstream Considerations For Biosimilar Development
    1/11/2021

    Understanding upstream challenges during biosimilar development and creating a strategy to overcome them is critical for ensuring a high chance of success with your biosimilar product.

REGULATORY COMPLIANCE SOLUTIONS

  • Researchers today have more information available to them than ever before. Patents, publications, Electronic Lab Notebook (ELN) entries, internal and external databases, and countless other sources all offer insights that can catalyze discovery. The challenge is finding the right information at the right time.

  • 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.

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

  • 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.

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