OFFERING TOP QUALITY, COST-EFFECTIVE REGULATORY COMPLIANCE CONSULTANCY SERVICES, ACROSS THE GLOBE.

OUR EX-FDA INVESTIGATORS, EX-FDA SENIOR POLICY ADVISOR AND INDUSTRY EXPERTS CAN HELP YOU TO REACH YOUR GOALS.

MMSTAN INC. offers result-oriented Regulatory Compliance Consultancy Services for companies seeking competitive advantage and compliance in various areas of GMP. Our Pharmaceutical consulting team includes ex-FDA drug Investigators, ex-FDA Senior Policy Advisors, and Industry Experts who have previously held leadership roles within the regulatory agencies and industry. We provide a comprehensive range of services, ensuring that all aspects of GMP are covered. Our Medical Device consultants have extensive knowledge of Medical Device regulatory requirements, including Medical Device classifications.

Our approach to current Good Manufacturing Practice (cGMP) is very concise. We provide quality documents to your staff and ensure they are followed and the results are documented.

We have GMP consultants who can work at your site under your direction on short notice for short—or long-duration projects. These include ex-FDA Drug Investigators, ex-FDA senior Policy Advisor Pharmaceutical Engineers, GMP compliance consultants, Validation consultants, Regulatory Affairs consultants, and Technical Document writers available at short notice at competitive rates.

We implement GLP and GMP Quality Management Systems, perform GMP audits, and offer practical recommendations for closing the identified gaps. Our GMP consultancy also offers GMP Training for Pharmaceutical, Biopharmaceutical, and other Life Science industries, including basic GMP training, GAMP 5 training, Investigation and Root Cause Analysis, CAPA, and ICH Q9 / ISO 14971 Quality Risk Management training courses.

Our Regulatory Compliance Consulting Services are adaptable to your specific needs. They include responding to USFDA Regulatory Audit Observations, Reviewing CAPAs and their Effectiveness Checks, and supporting remediation activities as needed. We also perform Data Integrity Audits and Remediation, C&Q for Facility, Utility, Equipment, Packaging Lines, Cleaning Validation and Computer Systems Validation, and Process Performance Qualification to meet PIC/S, ANVISA, EMEA, FDA, Health Canada, and TGA regulations.

Our team, which includes many experienced ex-FDA regulatory Experts, ex-FDA Senior Policy Advisors, Industry Experts, and Compliance consultants, is here to guide you in responding to Regulatory Action Items, Reviewing CAPAs, addressing Data Integrity issues, and understanding FDA 21 CFR Part 11 and Annex 11 regulations. We also excel in preparing sites for anticipated Regulatory Inspections and helping clients meet current Regulatory Compliance Requirements. However, our ultimate goal is not just to ensure immediate compliance, but to empower our clients with the knowledge they need to maintain their regulatory compliance in the long term.

MMSTAN INC. provides professional regulatory compliance consultancy services for Pharmaceutical, and Biopharmaceutical companies across the globe.

Leadership backed by experience, recognition and reputation.

Dr. Mathew T. Thomas has 34 exemplary years of experience of serving in numerous regulatory, management, and leadership positions at the U.S. Food and Drug Administration (FDA). He retired from the FDA in June 2023, after his last posting from 2017 to 2023 as the Senior Policy Advisor for the Office of Scientific Investigations (OSI) in the Center for Drug Evaluation and Research (CDER), where he was responsible for leading the development, coordination, and implementation of compliance policy programs and strategic initiatives, and communicating on topics pertaining to data integrity, data quality, and regulatory sciences.

He is a Physician with thirty-four years of experience in FDA Regulatory processes governing medical product development, involving Clinical Research, and Basic Science Research. Served the U.S. Government in senior diplomatic, leadership, and management positions that required top-secret clearance. Trained in the Management of Lipid Disorders, Clinical Pharmacology, Public Health, and Regulatory Sciences. Knowledgeable of Good Clinical Practice (GCP), Bioequivalence (BE), Good Laboratory Practice (GLP), Human Subject Protection (HSP), Post-marketing Adverse Drug Experience (PADE) reporting, and Risk Evaluation and Mitigation Strategies (REMS). Conducted Bioresearch Monitoring (BIMO) Inspections in about 25 countries (inspections of sponsors, contract research organizations, clinical investigators, Institutional Review Boards (IRB), Radioactive Drug Research Committees (RDRC), and Bioequivalence studies).

Participated in Post-marketing Adverse Drug Experience (PADE) Reporting Compliance Inspections and drug-related Risk Evaluation and Mitigation Strategy (REMS) Compliance Inspections. Possesses expertise in regulatory review, report writing, guidance development, and policy development covering FDA-regulated drugs, devices, biologics, and tobacco products. Delivered training and presentations on behalf of the USFDA to domestic and international audiences. Supported clients, particularly in managing regulatory enforcement actions, which included prevention, remediation, and certification of sustainable results.

Mathew George has over thirty years of experience in Life Sciences, Project Management, Validation, Technical Services, and Quality including Sterile (injectable and ophthalmic), Non-sterile (solid and liquid) dosages and API Manufacturing. He held leadership positions at DuPont Merck, Pfizer USA and Pfizer India. Provided industrial expertise in the development of quality systems, implementation, validation strategies and good practices. Supported clients particularly in response and managing regulatory enforcement actions, which included prevention, remediation and certification of sustainable results. Experienced in Interim Control for Consent Decree (CD), Warning letter (WL), and 483 activities.

Performed many regulatory compliance audits and remediation work for Pharmaceutical, Biopharmaceutical and Medical Device Industries. Expertise includes Data Integrity Audits and Remediation, CAPA, BMR & BPR Reviews, CSV and Equipment Qualification (Manufacturing, Packaging and Laboratory), Utility Qualification and Control Systems Validation. Performed domestic and international Data Integrity Audits and created remediation plan for gaps identified in Laboratory and Manufacturing Systems. Created, reviewed and approved Change Controls, Event Reports, ALIR and CAPA.

Proven knowledge about SDLC, cGMP, GLP, GCP, GAMP, QA/QC, MHRA, EMA, ANVISA, MFDS, WHO, Health Canada, FDA, 21 CFR 210, 211, Part 11 Regulations, ISPE and ICH Guidelines. Worked as a Lead Auditor for Pfizer and written audit reports. Created Risk Assessments based ICH Q9, NIST and GAMP for various systems used in Pharmaceutical, Biopharmaceutical and Medical Device Industries.

Performed Compliance Audits for API Plants, reviewed Batch Records and remediated action items. Also, audited CMO and CDMO Facilities and performed Pre-Approval mock audit for Continuous Manufacturing Process and Control Systems. Provided 483 Responses and status update for US FDA Audits. Experienced in leading QMS platforms such as Trackwise, MasterControl, ETQ, and Veeva Vault QMS.

Collaborated with the Senior Leadership of Quality and Regulatory within the Medical Device Industry Business Unit and Regions, to implement and maintain a unified, flexible, efficient and robust Quality System. Maintained and updated Quality procedures and all other Quality Records (including Technical File, Device Master Records and Device History Records).

Quality Assurance experience within an FDA regulated industry, Devices or diagnostics. Working knowledge of 21 CFR820, ISO 13485:2016, MDD, IVD, MDSAP and other global regulations. Experienced with sterile medical devices.

Diane K. Gates brings over 20 years of experience in the pharmaceutical and biopharmaceutical industries, as well as a Cleaning Validation SME with hands-on experience in developing cleaning validation strategies, Remediation efforts to prevent Cross-Contamination, Reviews of Deviation, Investigation and CAPA, evaluating Quality Management Systems, authoring and reviewing Cleaning Validation Master Plans, Cleaning Validation Protocols and Reports, Enhancement of Cleaning Validation Procedures and conducting Training of personnel responsible for various Cleaning Validation activities. Performed GMP Audits and participated in Remediation Activities.

Diane has played a pivotal role in validation and quality assurance, contributing to established pharmaceutical companies and innovative start-ups. Diane has provided exceptional quality oversight for autologous immunotherapies, combination products, and biologics, showcasing her extensive expertise in these areas. Diane has conducted Compliance audits and remediated various Compliance issues for Cleaning Validation at various manufacturing sites. Evaluated cleaning practices, provided recommendations, assisted in investigations, and helped determine root causes and CAPA for CV failures at several manufacturing sites. Conducted GMP and Cleaning Validation Training Sessions for QC, QA, and Validation personnel. Authored, Reviewed, and approved Validation Protocols and Reports, Non-Conformances, SOPs, Master Validation Plans, Gap Analysis, Cycle Development Protocols and Reports, Engineering Study Protocols and Reports, Commissioning and Qualification Plans and Reports, Requalification Protocols, Reports.

Diane assisted the QC labs in developing the analytical techniques for testing and cleaning validation samples following GLP guidelines. Performed recovery studies for swabbing from several MOCs. Defended the site cleaning validation practices to the FDA. Played a key role in qualifying several autoclave load configurations to meet European regulatory standards, ensuring compliance. Supervised the activities of technicians performing the validation projects for autoclaves in media production. Qualified several incubators, chill rooms, hoods, Lyophilizers, and classified production areas. Developed SIP procedures for several reactors, fermenters, and skids. Performed media challenge studies for several aseptic production and filtration systems. Participated in the tech transfer, scale-up, and process validation projects.

Responsible for oversight of aseptic process validation and subsequent media fill operations. Responsible for managing technology transfer activities from process development to manufacturing, including reviewing and approving associated technical reports and leading process risk assessments supporting Process Control Strategy development Product line SME. Provided statistical analysis of in-process data for the adjustment of release criteria. Completed updates on site process validation master plans and charts and oversaw technical process transfer into a new facility. Provided technical assistance for manufacturing deviations and batch document review. Responsible for compiling and assessing all validation activities within multiple product APQR documents. Participated in the development of upstream and downstream production processes. Performed media challenge studies for several aseptic production and filtration systems. Participated in the tech transfer, scale-up, and process validation projects.

Dr. Prakash Kulkarni has over thirty years of experience in the pharmaceutical industry (sterile and non-sterile facilities), including successful project management, validation, technical services, and quality. His track record of successful project management instills confidence in his leadership skills. He has provided industrial expertise in product and process development, process and packaging validation, equipment qualifications, technology transfers, several ANDA filings, and responses to deficiency letters. Experience in solid orals and sterile product manufacturing. API and Excipient audits and Due Diligence activities. With knowledge of cGMP, GLP, GCP, QA/QC, MHRA, EMEA and FDA Regulations and ICH Guidelines, he has supported the management of regulatory enforcement actions, including remediation and certification of sustainable results for FDA 483s, Warning Letter, and Consent Decrees.

His strong technical background in Pharmaceutics and Pharmaceutical Sciences is underpinned by his proven problem-solving skills. His extensive experience in product development, including solid orals, liquid and semi-solids, soft gelatin capsules, and sterile products, is a testament to his ability to handle challenges. He has a wealth of experience in process Validation, Equipment Qualification, Packaging Validation, and Cleaning Validation. His work includes the development and ANDA filings for generic products, including 505 (b) (2) filings, as well as NDA products. He has also developed and executed the Tech Transfer Strategy and Plan, performed FDA Pre-approval inspections, and handled Deficiency letters for ANDAs/Amendments. His skills extend to conducting annual Product Reviews, investigations / CAPA for non-conformities, and performing remediation activities. He is adept at Root Cause Analysis and Quality Risk Management. Dr. Prakash also conducts GMP Audits for APIs, Excipients, and Finished Dosage.

Dr. Prakash has reviewed SAP modules for TrackWise software validation, a crucial step in ensuring the accuracy and reliability of pharmaceutical processes. He has also developed C & Q documents and reviewed Risk Assessments on Equipment and Control and Alarm Systems, demonstrating his attention to detail and thoroughness. Dr. Prakash has reviewed change controls, validation plans, and Risk Assessments, and has also reviewed stability programs and procedures for OOS/OOT investigations. He has developed Site Master Validation Plans, written SOPs, protocols, and master plans. Dr. Prakash has helped client manufacture products via tech transfer under interim control while under the consent decree, and has assisted clients in managing FDA 483 responses, CAPA reviews, closure, and verification under Warning Letter and Consent Decree.

Joel Gates brings over 25 years of experience in the pharmaceutical and biopharmaceutical industries. He is a Microbiologist by training and has held key leadership roles in Validation, Engineering, Quality Control, Quality Assurance, and Operations. His extensive experience has been a driving force in the success of established pharmaceutical companies and innovative start-ups. Joel has led companies through multiple start-up activities and pre-approval inspections, demonstrating his ability to navigate complex situations. He has also led the quality and operations functions during routine cGMP manufacturing. His work with regulatory agencies across the globe, including FDA, Health Canada, ANVISA, TGA, KFDA, and others, underscores his commitment to ensuring that pharmaceutical firms meet regulatory expectations as efficiently and effectively as possible.

Joel was responsible for the cleanroom manufacturing facility, including EM monitoring and contamination control strategies, process sterility assessments, establishing microbial heat maps for critical processes, and performing risk and impact assessments associated with environmental excursions. Developed a process heat map showing areas of highest risk for microbial contamination, ranked these risks, and implemented required mitigations to limit risks. This included media simulations for verification purposes. Conducted US FDA Pre-Approval Mock Audits, M & A Due Diligence Audits, and GxP Compliance Audits for numerous GMP pharmaceutical and biological drug manufacturers. Assisted clients with their written communication to the FDA and remediation, resulting in removal from an Import Alert after passing the FDA reinspection. Created, reviewed, and performed facility qualification, equipment qualification, utility qualification, process validation, and cleaning validation.

Joel, created, reviewed, and implemented Change Control & CAPA commitments resulting from internal audit, customer audit, and agency inspection observations to verify implementation and effectiveness check. Provided training on CAPA, investigation, DI, validations, and auditing of biotech facilities. Provided oversight of all Quality Assurance activities at the two manufacturing facilities, a cell banking facility, and a large-scale development lab. Performed additional QC oversight, including a review of all OOS and OOT results (Raw material, in-process, and final product testing). Created and reviewed process-related trends, significant investigations, manufacturing trends, alarm trends, and quality metrics (disposition cycle time, deviation rate, deviation cycle time, change control, overdue quality records, batch record review times). Participated in the development of upstream and downstream production processes. Performed media challenge studies for several aseptic production and filtration systems. Participated in the tech transfer, scale-up, and process validation projects.

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