VALIDATION CONSULTING

Equipment Qualification
Process Validation
Computer System Validation
Cleaning Validation
Analytical Method Validation

C&Q

Manufacturing Equipment Qualification
Packaging Equipment Qualification
Utilities Qualification
FAT
SAT

Welcome to MMSTAN INC., a premier, NY-based professional regulatory compliance consultancy providing a full scope of regulatory compliance services and products for Pharmaceutical, Biopharmaceutical, and Medical Device companies across the globe.

Our Ex-USFDA Drug Investigators and Industry Experts assist in responding to USFDA regulatory observations with CAPA action items and remediation efforts with sustainable compliance-oriented solutions, making MMSTAN INC. a distinctive name in consultancy.

MMSTAN, with a proven track record in preparing sites for USFDA Inspections and assisting companies in addressing regulatory observations, offers result-oriented compliance meeting the current regulatory requirements to Pharmaceutical, Biopharmaceutical, and Medical Device companies across the globe.

  • Supported clients particularly in managing regulatory enforcement actions, which includes prevention, remediation and certification of sustainable results
  • Simple, cost effective, compliant and effective solutions to our clients to meet their goals with detailed support throughout the project life cycle
  • US FDA Pre-Approval Mock Audits, M&A Due Diligence Audits and GxP Compliance Audits for GMP and Pre-Approval Inspections of pharmaceutical and biological drug manufacturers
  • Regulatory bandwidth coupled with time proven and agency weathered methodologies that lower client risk
  • Draft Warning Letter and FDA 483 observations' response letter to FDA, Remediate gaps as needed. Assist during Regulatory Audits
  • Provide recommendations for facility design, construction, or operation from a compliance perspective
  • Assurance of independent, expert deliverables
  • Harmonized compliance efforts across diverse business software systems, for globally dispersed facilities and complex regulatory requirements
  • Result oriented, client-tailored approach has successfully assisted numerous multinational companies to be in compliance with both domestic and international regulatory bodies
  • Providing Interim Control for Consent Decree activities in major US Pharmaceutical Companies
  • Multidisciplinary team of consultants to perform system implementations under the FDA Consent Decree environment
  • Project Management functions (Initiation, planning, execution, control, etc.) to assure certification for manufacturing sites
  • Tireless and dedicated consultants assigned to your project help deliver sustainable results

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