Stan

About Stan

MMSTAN INC. is a premier, professional validation consultancy providing a full scope of regulatory services and products for Pharma, Biopharma, and Medical Device companies across the globe. Our sustainable compliance oriented solutions makes MMSTAN INC, a distinctive name in consultancy. MMSTAN provides quality, regulatory and compliance services offering • Cost effective and compliance oriented validation solutions to our clients. • Provide validation and/or compliance audits and recommendations and/or validation services • Regulatory bandwidth coupled with time proven and agency weathered methodologies that lower client risk • 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 COMPLIANCE CONSULTING includes Quality Systems, Regulatory Audits, GMP Trainings VALIDATION CONSULTING includes Equipment Qualification (Manufacturing, Packaging and Lab), Process Validation, Computer System Validation, Cleaning Validation, Analytical Method Validation C&Q

Experience

1. Independent Consultant for Large Small, Sterile Non-sterile, Pharma Bio Pharma Companies

   Mmstan Inc

   Jan 2010 — Present · New York, NY, US

   Knowledgeable, experienced consultants partnering with unique solutions to achieve your goals in Pharmaceutical, Biopharmaceutical and Medical Device companies.MMSTAN INC. is a premier, professional validation consultancy providing a full scope of regulatory services and products for Pharma, Biopharma, and Medical Device companies across the globe.Our sustainable compliance oriented solutions makes MMSTAN INC, a distinctive name in consultancy.MMSTAN provides quality, regulatory and compliance services offering• Cost effective and compliance oriented validation solutions to our clients.• Provide validation and/or compliance audits and recommendations and/or validation services• Regulatory bandwidth coupled with time proven and agency weathered methodologies that lower client risk• 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 resultsCOMPLIANCE CONSULTING includes Quality Systems, Regulatory Audits, GMP TrainingsVALIDATION CONSULTING includes Equipment Qualification (Manufacturing, Packaging and Lab), Process Validation, Computer System Validation, Cleaning Validation, Analytical Method ValidationC & Q

Skills

• Compliance Management
• Validation
• User Acceptance Testing
• Cgmp Manufacturing
• Sdlc
• Consent Decree
• Fda Gmp
• Regulatory Compliance
• V&V
• Biopharmaceuticals
• Computer System Validation
• Pharmaceutical Industry
• Cgmp Practices