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More info about MENE Research

Regulatory Management

MENE Research

Mene Research Regulatory Group efficiently manages and successfully executes all aspects of global start-up according to Sponsor specifications.

  • Perform quality checks on submission documents and site essential documents;
  • Interact with Authorities, CEC, EC, sites, and international associates;
  • Prepare and approve and adopt to local requirements of informed consent forms;
  • Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
  • Present during bid defenses, general capabilities meetings, and audits
  • Ensure that the sections are complete, well written, and meet all relevant requirements. Develop excellent relationships with internal functional groups; contract manufacturing organizations, and partners.
  • Facilitate device clinical trial and commercial application/registration by providing timely, relevant, targeted regulatory intelligence
  • Develop and continuously maintain the regulatory knowledge management tool

 

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