Welcome to MMSTAN INC., a leading Regulatory Compliance Consultancy based in New York. We are dedicated to delivering a comprehensive suite of Regulatory Compliance Services and Products tailored specifically for Pharmaceutical, Biopharmaceutical, and Medical Device companies worldwide.
What sets us apart is our team of former U.S. FDA Drug Investigators and Industry Experts, who are committed to guiding clients through the complexities of U.S. FDA regulatory observations. We help our clients to respond effectively to these observations and implement robust corrective and preventive action (CAPA) strategies and remediation efforts, focusing on sustainable, compliance-oriented solutions that position MMSTAN INC. as a trusted partner in regulatory compliance consultancy.
MMSTAN , with a proven track record of preparing sites for US FDA inspections, we empower organizations to address regulatory observations proactively. Our result-driven compliance strategies are designed to meet and exceed current regulatory requirements, ensuring that Pharmaceutical, Biopharmaceutical, and Medical Device companies worldwide achieve and maintain the highest compliance standards. Partner with MMSTAN INC. and transform your regulatory challenges into opportunities for excellence.
- Supported clients in managing and responding to regulatory enforcement actions, including prevention, remediation, and certification of sustainable results.
- Simple, cost-effective, compliant, and effective solutions to meet our clients' goals with detailed support throughout the project life cycle.
- US FDA Pre-Approval Mock Audits, M&ADue 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 a warning letter and FDA 483 observations response letter to the FDA, and 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.
- A result-oriented, client-tailored approach has successfully helped numerous multinational companies comply with domestic and international regulatory bodies.
- Providing Interim Control for Consent Decree activities in major pharmaceutical companies that market their products in the U.S.
- A multidisciplinary team of consultants will perform system implementations under the FDA Consent Decree environment.
- Project Management functions (Initiation, planning, execution, control, etc.) are used to assure certification for manufacturing sites.
- Tireless and dedicated consultants assigned to your project help deliver sustainable results.
