Our services
Five engagements built around one goal: a clean inspection record.
Form 483 & Warning Letter Responses
We help you draft clear, defensible, and technically sound responses to FDA observations — with realistic timelines and CAPA commitments your team can actually deliver on.
Remediation Plans
Beyond the initial response, we help you design and execute a remediation plan that addresses root cause, not just the symptom the FDA flagged.
Mock Pre-Approval Audits
Before the FDA arrives, we run a mock audit that mirrors real inspection conditions — surfacing gaps in documentation, procedures, and facility readiness while there's still time to fix them.
Vendor Audits & Due Diligence
We assess suppliers, CMOs, and contract testing labs against CGMP expectations, giving you clear visibility into third-party risk before it becomes your risk.
Regulatory Submissions Review
We review submissions for regulatory accuracy and completeness, helping reduce the risk of delays, deficiency letters, or follow-up information requests.
How an engagement runs
Four stages, start to finish.
Assess
We read the finding, the file, and the facility — before we write a word of response.
Respond
A defensible, technically sound response with commitments your team can meet.
Remediate
Root-cause fixes to the systems behind the finding, not just the paperwork.
Verify
A mock audit or documentation check to confirm the fix holds under scrutiny.
From our desk
Recent thinking on FDA compliance.
Reading a Form 483: What Investigators Actually Flag
The difference between an isolated observation and a pattern — and why it changes your response.
Data Integrity Under ALCOA+: Where Manufacturers Still Fall Short
The gaps that keep showing up in electronic batch records and audit trails.
Preparing for a Pre-Approval Inspection: A 90-Day Checklist
What to close out first once the clock starts running.