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Regulatory Operations

Regulatory Operations (RegOps) can provide the greatest ROI of any department development activities.  A fully developed RegOps group will free your Regulatory Managers and Directors from the onerous tasks of publishing, document control and archiving.

To maintain proper document control, these activities can take up to 30-50% of a typical Regulatory Manager’s time.  Regulatory Operations places these activities as well as the support of all Regulatory Systems within one sub-group of specialists.  Without a strong RegOps group, your department will not be able to optimize the work of your Regulatory Professionals and you increase the risk of falling out of compliance and receiving a 483.

Aquila specializes in assisting Small to Medium sized Pharma, Biologic, and Medical Device companies develop a self-sustaining RegOps group.

  1. Assist you in developing internal workflows,
  2. Justify the financial expense in systems and people.
  3. Help you identify any systems you may need to implement.  This can range from simple document tracking through a full EDMS and publishing system.
  4. Author draft SOPs and WIs
  5. Support Computer Validation Projects
  6. Provide Project Management for any implementation
  7. Provide training to RegOps personnel
  8. Provide on-going support as you grow

 

What Clients Say

"I was surprised to discover that an initial application takes up to 2,000 man-hours to publish but Aquila helped us finalize our application in months instead of a year!" - Director of Regulatory

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