MMSTAN
MMSTAN INC. is a leading Regulatory Compliance Consultancy based in New York, specializing in services for Pharmaceutical, Biopharmaceutical, and Medical Device companies worldwide. Their team of former FDA investigators and industry experts provides comprehensive regulatory compliance solutions, including audit preparation, remediation, validation, and training, with a focus on sustainable, compliance-oriented results and long-term client empowerment.
Industries
Nr. of Employees
small (1-50)
MMSTAN
New Hyde Park, New York, United States, North America
Services
Advisory and implementation services to prepare for regulatory inspections, respond to observations, and implement corrective and preventive actions to achieve sustained compliance.
Equipment, process, cleaning, and computerized system validation services including IQ/OQ/PQ, process validation, analytical method validation, and AIQ.
Execution of internal, supplier, contract manufacturer, API manufacturer, and M&A GMP audits with tailored corrective action plans.
Comprehensive audits of laboratory and manufacturing data systems and execution of remediation plans to address integrity and compliance gaps.
Training programs and on-the-job knowledge transfer for validation and quality engineers covering cGMP, CSV, CAPA, and risk management.
Integrated commissioning and qualification services for facilities, utilities, manufacturing equipment and packaging lines to ensure regulatory compliance through design, construction, and start-up.
Advisory and implementation services to prepare for regulatory inspections, respond to observations, and implement corrective and preventive actions to achieve sustained compliance.
Equipment, process, cleaning, and computerized system validation services including IQ/OQ/PQ, process validation, analytical method validation, and AIQ.
Execution of internal, supplier, contract manufacturer, API manufacturer, and M&A GMP audits with tailored corrective action plans.
Comprehensive audits of laboratory and manufacturing data systems and execution of remediation plans to address integrity and compliance gaps.
Training programs and on-the-job knowledge transfer for validation and quality engineers covering cGMP, CSV, CAPA, and risk management.
Integrated commissioning and qualification services for facilities, utilities, manufacturing equipment and packaging lines to ensure regulatory compliance through design, construction, and start-up.
Expertise Areas
- Regulatory compliance and FDA inspection readiness
- Quality systems design and GMP implementation
- Validation and qualification (equipment, process, CSV, cleaning)
- GMP auditing and remediation
Key Technologies
- PLC/SCADA/DCS control systems
- Continuous manufacturing systems
- Analytical instrument qualification (AIQ)
- Computerized system validation (CSV) and 21 CFR Part 11 assessments