MMSTAN is a team of distinguished former U.S FDA Drug Investigators and Industry Regulatory Experts with extensive experience in supporting global regulatory expectations and needs within the life sciences sector.  Our business model is proven and effective, built on a strong track record of delivering results, earning referrals, and securing repeat engagements from satisfied clients.

We have an outstanding track record of assisting numerous firms in achieving No Action Indicated (NAI) or Voluntary Action Indicated (VAI) status during inspections. MMSTAN provides cost-effective compliance solutions throughout the pharmaceutical product lifecycle for drugs, biologics, and medical devices. Our commitment to ensuring the highest quality of services is unwavering, and you can trust that our work will always meet the most stringent standards.

Our Mock Audits are designed to replicate real inspections, such as FDA General GMP Inspections or Pre-Approval Inspections (PAI). These audits help identify compliance gaps, train staff on procedures and questioning techniques, and promote a culture of preparedness for actual audits. By identifying deficiencies early and implementing actionable Corrective and Preventive Actions (CAPAs), we aim to reduce risk and enhance our quality systems.

MMSTAN INC.

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