From Consent Decrees
to Continuous Compliance—
Expert GMP Remediation, Now AI-Enabled.
20+ years of GMP remediation expertise
combined with Moe 2.0, a proprietary AI employee training software,
ensure that your company's investigations and CAPAs are uniform and audit-ready,
while providing learning opportunities for your team.
Trusted by pharma leaders for FDA remediation, training, and investigation improvement.
Moe 2.0: Real-Time Training for Investigation Excellence
• Accelerates learning: real-time AI feedback
• Raises rigor: teaches evidence-based thinking
• Scales easily: consistent coaching across teams
Services
503B Quality Systems Auditing and Gap Analysis
Conduct deep-dive audits across:
• compounding operations
• environmental monitoring
• aseptic process control
• documentation integrity
Investigation and Backlog Remediation
Clear deviation backlogs with speed and consistency.
Root Cause Analysis & Effective CAPAs
Understanging Root Causes leads to strong CAPAs to eliminate repeat issues.
Training and Culture Transformation
Build staff capability through traditional training and coaching augmented with real-time AI mentoring.
Our Approach
Root Cause GMP Remediation
Molewyk Regulatory Solutions conducts thorough and efficient investigations for facilities under warning letters and consent decrees, with a focus on identifying and correcting root causes instead of managing symptoms. In the process, we transform quality systems from organizational liabilities into organizational strengths.
AI-Augmented Consulting
At Molewyk Regulatory Solutions, we combine hands-on consulting with the power of Moe 2.0, our proprietary AI-enabled training and mentoring app. While a consultant leads remediation and investigation strategy on-site, Moe 2.0 concurrently turns each deviation into a training opportunity, by providing client employees with instant, rubric-based feedback while they’re actually writing the deviation.
As a result, employees learn faster and better because they receive just-in-time training on the job, rather than theoretical training in a classroom. Over time, this builds an organization of confident investigators who write clear, consistent, and audit-ready reports. In addition, by integrating Moe 2.0 into the workflow, every investigation meets a uniform standard of quality, with structure and reasoning that withstands FDA and third-party review.
Continuous Improvement Mindset
Remediation is the start, not the finish line. We help clients convert what they learn during crisis recovery into sustainable processes—embedding risk management, root-cause thinking, and scientific rigor into everyday operations. Each deviation becomes a learning loop that strengthens the system and reduces future errors from happening.
