We guarantee that our interventions will improve your U.S. FDA regulatory postion,
provided that you implement and maintain the agreed-upon systems / procedures.
It is your responsibility to keep up with changes in industry practices and/or
regulatory requirements and make any necessary corrections, modifications, or
additions.
It is your responsibility to insure that your personnel also receive the
necessary training, at the required intervals, and that your senior management
is fully involved (and supportive) in reviewing these compliance activities.
Of course, J. E. Lincoln and Associates LLC provides assistance in these areas as well.
If your company fulfills its responsibilies, and an issue still arrises with the
Agency regarding one of our interventions, we will assist you in meeting with
the local (SLC, UT) Resident Post, and/or in preparing your corrective
actions / responses, and/or an Action Plan / Gantt Chart, at no additional
charge to you.
This guarantee would only apply to the first U.S. FDA compliance audit after one of
our interventions addressing that particular area in question.
This guarantee applies only to issues between your company and the U.S. FDA, not
to differences in opinion with other consultants, new hires / managment changes
(including sale of the company), or vendor or similar audits
(e.g., Notified Body
ISO 13485 / 9001).
The specifics would be addressed in a written proposal.
To our knowledge, we are unique in the industry in providing this guarantee.