FDA Products & Services

  1. Enterprise Asset Performance Management Software for Life Sciences, Pharma

    Technology, enabled by the Industrial Internet of Things (IIoT), is empowering organizations to shift to a holistic and operations-centric view where proactive and predictive maintenance (PdM) enables front line personnel in life sciences to act before costly failures occur.

  2. Powder Transfer Process

    EZ BioPac is meeting the challenges of biopharmaceutical powder manufacture. The EZ BioPac single-use system is the fastest, most efficient solution. Its larger diameter top opening permits easy filling and fine-tuning of final weight. 

  3. Regulatory Services

    If you need help preparing and submitting your API regulatory applications, Cedarburg Hauser Pharmaceuticals has the knowledge and experience it takes to efficiently guide you through the complexities of the FDA submission process.

  4. Regulatory

    JHP Pharmaceuticals has an experienced in-house Regulatory Affairs department capable of assisting you with Clinical Trial Applications, New Drug Submissions, and Supplements.

  5. Adverse Event Reporting, Safety and Compliance Software

    Adverse event (AE) reporting is a key process point for maintaining safety and compliance. Unfortunately, it’s also incredibly labor-intensive. AE source documents arrive in just about any form—mail, fax, email, even voice records from call centers.

  6. LF-S BenchTop Single-Head Leak Testing Machine

    The Leak Testing Machine is used for off-line Non-Destructive Container Closure Integrity Testing. It performs the Leak Testing process on one Container at a time by means of a Testing Chamber under Vacuum or Pressure.

  7. Drug Safety Issue Tracking Software
    Monitoring and tracking the efficiency and accuracy of organizations’ drug safety reporting process can help to ensure issues are logged and investigated when they arise, avoiding delays and/or inaccurate reporting which can result in lack of regulatory compliance, monetary fines, and unwanted scrutiny.
  8. Drug Safety Software Adverse Event Reporting
    TrackWise by Sparta Systems’ Adverse Event Reporting solution tracks reported adverse events and manages the processing of all cases from initial triage through reporting and case closure.
  9. Drug Safety Audits Software
    Without a means to track and schedule, drug safety audits tend to be performed on an irregular basis, typically resulting in disconnected audits with recommendations that not followed up on.
  10. CAPA Software
    The TrackWise by Sparta Systems Corrective Action and Preventative Action (CAPA) solution for the pharmaceutical and biopharmaceutical industries automates CAPAs precipitated by deviations, complaints, and other quality processes.