Regulatory Solutions

  1. DocuShare Compliance Module

    The DocuShare Compliance Module is an ideal solution for any organization seeking to provide control over electronic documents and their associated business processes.

  2. Regulatory Affairs
    Our team of Regulatory Affairs experts plays a pivotal role in your project from initiation to completion, ensuring compliance with applicable laws and regulations throughout the process.
  3. ePRO Knowledge Center
    These published documents from the FDA and ISPOR support the use of ePRO in clinical trials.
  4. Regulatory Submissions
    Regulatory submissions are the most critical milestones in your clinical research program. Quality submissions can accelerate time to market, bring the benefit of new treatments to patients sooner, maximize research investments, and conserve patent life.
  5. Regulatory Affairs

    As the clinical development of new medical products becomes more complex, so has the route to regulatory compliance that ensures patient safety and regulatory compliance.

  6. EMC Documentum Quality Manufacturing Solution For Life Sciences

    Quality & Manufacturing organizations in Life Sciences companies are facing more pressure than ever to run efficient, uninterrupted production at the lowest possible cost, while meeting stringent safety, quality, and regulatory standards.