Welcome to MMSTAN INC. is a premier, 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-FDA Drug Investigators and Industry Experts provide sustainable compliance oriented solutions makes MMSTAN INC., a distinctive name in consultancy.
MMSTAN provides quality, regulatory and complaints products, and services to the Pharmaceutical, Biopharmaceutical and Medical Device companies across the globe by offering:
- 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
