Regulatory & Compliance

Our regulatory solutions are customized to your specific needs.  We can give your staff the information they need to deliver your customized solution, or augment your staff (from associate to executive level), to meet your goals/objectives.  Solutions and areas of expertise include, but are not limited to:

  • Regulatory strategy (Pharma/Biologics/Medical Device/Combination products)
  • Orphan, Fast-Track, Breakthrough and RMAT designation strategy and submissions
  • Collaboration with military branches
  • Regulatory submissions
  • Medical writing
  • FDA meetings
  • FDA Advisory Committee meetings
  • EMA meetings
  • Notified body meetings
  • Regulatory operations – Compliant electronic regulatory submissions
  • REMS strategy
  • Post-approval product support
  • Medical safety submissions (pre and post-market)
  • Recalls and corrective actions
  • Labeling compliance
  • Advertising and Promotion
  • RA staff augmentation (associate to executive level)

The regulatory team includes expert regulatory program managers to track and manage program timelines, critical paths and key milestones, allowing your internal teams to focus on their areas of expertise and facilitate product development.

EVERSANA’s regulatory program management consulting services include:

  • Lead large cross-functional project teams on challenging projects
  • Project management training
  • Program or project charters that define scope and goals
  • High-level and detailed network-based schedules
  • Task identifications, including durations, responsibilities and resources
  • Validation of schedule
  • Staffing analysis
  • Establishment of program/project governance procedures, standard reports, and metrics
  • Implementation of MS Project
  • Generation of status memos for key stakeholders
  • Training on the use of project management tools/methods
  • Maintain up-to-date project files
  • Ensure websites, shared drives and databases for project are updated
  • Serve as an onsite expert in project management
  • Project management mentoring
  • On-site project office development

Need Advisors Focused Exclusively On The Life Sciences Industry?