Regulatory Compliance Solutions

  1. Palltronic® Flowstar V Integrity Test Instrument 3/10/2022

    Filter integrity testing reaches a whole new level with the Palltronic Flowstar V featuring higher safety margins with a plug-and-play network integration.

  2. Clinical Pharmacology Services 3/14/2025

    With over 30 years of proven experience, we provide comprehensive clinical pharmacology services, from data management and analysis to the generation of clinical study reports.

  3. Class 2 Biological Safety Cabinet 8/29/2023

    The Class 2, Type A2 Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area of the biological safety cabinet is continuously bathed with laminar flow ISO 5 HEPA-filtered air to protect the product from contamination while an inward airflow protects the user. Approximately 70% of the air from each cycle is recirculated through the supply HEPA filter while the remaining air is discharged from the biosafety cabinet through the exhaust HEPA filter. These biosafety cabinets eliminate cross-contamination and the accidental release of carcinogenic aerosols and drugs to the outside environment.

  4. Scientific Insights Lab Simplifying The Journey From Molecule To Market

    Drug development programs should aid customers in the successful mitigation of technical and regulatory risks to ensure drug products move swiftly through the regulatory approval process and into commercialization. Get service and support to help pharmaceutical and biopharmaceutical manufacturers Simplify the Journey™ from molecule to market.

  5. X-Ray Inspection Solutions For The Pharmaceutical Industry 2/6/2025

    Pharmaceutical manufacturers face many challenges, from safeguarding brand reputation and protecting consumers' welfare to complying with legislative and regulatory standards.

  6. Bioproduction Regulatory Consulting Capabilities 12/20/2022

    Learn more about a service that provides regulatory support, validation guidance, internal consultations, and industry organization guidance while your company implements bioproduction solutions.

  7. Pharmaceutical Automation And Information Technology Services 12/21/2020

    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.

  8. Biosafety Testing 6/2/2025

    Biosafety testing ensures biologics' safety and quality but faces challenges like cost, time, and technical complexity. Proper planning and regulatory compliance are key to success.

  9. Cleanrooms And Equipment For 503B Outsourcing Facilities 6/9/2023

    Germfree understands the unique challenges associated with 503B sterile drug compounding

    Sterile drug compounding involves preparing customized medical formulations to address individual patient needs. Key challenges include guaranteeing medication safety and efficacy, adhering to FDA regulations, and managing suitable environmental conditions during the process. Improper compounding can be hazardous, making compliance with standards like USP <797> and <800> vital. 503B providers must also follow FDA regulations, including cGMPs, for outsourcing facilities.

  10. FDA-Registered Detergents 10/7/2020

    All Alconox Inc. detergents are Class I Medical Devices and listed as FDA-registered detergents. The list of the detergents is found on the FDA website with FDA Registration number 2410887. Alconox Inc. is also proud to be ISO9001:2015 and ISO13485:2016 Certified.