After a Form 483 or a warning letter, the work changes. Deadlines are set by the agency, and every document you produce may be read by an investigator. Our consultants have done this work before, including warning letter remediation and consent decrees.
If you are going to respond, FDA expects it within 15 business days. We help you understand each observation and write a response that shows you have found the real problem.
Once you have promised FDA a remediation plan, you have to deliver it on schedule. We help write the plan and do the work.
Mock inspections, documentation review, and cleanup before the investigators arrive.
Remediation means a lot of changes in a short time. Each one still has to go through change control, and deviations still have to be closed.
Help for companies operating under a consent decree.
A drug manufacturer has received a warning letter and committed to a remediation schedule. It needs a compliance lead and a CSV specialist to meet those dates.
A biotech is facing its first pre-approval inspection. It needs a mock inspection, a review of its documentation, and confidence that its electronic records will hold up under Part 11 and Annex 11.
A CDMO is adding clients faster than its quality system can absorb them. It needs a contract Quality Systems Manager who has run a multi-client GMP operation.
A remediation or readiness program with milestones set by your commitments to FDA or your inspection date.
A compliance lead or CSV specialist who joins your team to help meet your remediation commitments.
Share your situation and the systems involved, and we will outline how we would approach it.