Our team is a unique combination of passionate pharmaceutical quality assurance (QA) and information technology (IT) professionals that include global GxP auditors, IT, and QA. The team brings in-depth knowledge of international regulatory requirements, current compliance trends, and guides to maintain compliance. We work with our clients to ensure global requirements are met, and clients maintain compliance.
Mr. Thakker is a visionary with hands-on expertise that spans 30 years in CGMP / Cell Therapy Quality Systems, CSV (Computerized System Validation), ERES (Electronic Record/Electronic Signature), Data Integrity, and regulatory compliance.
Throughout his career, he has continuously refined his ability to interpret, simplify, and implement the US FDA CGMP regulatory requirements effectively. He believes in simplifying processes to reduce time, effort, and compliance costs.
Serving as a Global CSV, CGMP, and Cell Gene Therapy Process and Apheresis Auditor, he has conducted nearly 200 audits worldwide. He has played a pivotal role in regulatory compliance by overseeing health authority inspections, conducting mock inspections, and designing global quality systems.
As a global speaker, he has contributed to compliance awareness through speaking engagements on topics like Inspection Readiness, Training, and Validation. His contributions to industry guidance include leadership in the development of the GAMP-based "Risk Based Commissioning and Qualification" chapter 11 for the 2009 ISPE Baseline Guideline.
His key strengths lie in leadership, team building, and commitment to supporting team members. As a subject matter expert and mentor, he possesses a deep understanding of global regulatory requirements, including US FDA 21CFR, EU regulations, and many other international regulatory requirements.
In 2009, he founded a company and experimented with a next-generation single computer system validation solution, which evolved into the OC11 Word SaaS cloud platform. This platform integrates logical global GxP, data integrity algorithms, artificial intelligence, and a single computer system validation solution.
His vision is to provide an affordable easy to use computerized solution to manage extremely complex pharmaceutical, biotech, medical device, blood bank, and cell therapy global regulatory compliance to a single testing laboratory to a large global GxP (Pharmaceutical Drug, Cell Therapy, clinical, etc.) operations with multiple sites.
Dr. Molina holds a Ph.D. in Pharmaceutical Sciences from the University of Colorado. She has more than 17 years of combined biotechnology and pharmaceutical industry experience in regulatory affairs and drug development of vaccines, gene therapy, biologics and small molecules.
Throughout her career, she has played a pivotal role in Global Regulatory Affairs for the development of biologics, vaccines (live attenuated bacteria, prophylactic and therapeutic mRNA), mRNA-based technologies for molecular therapies and small molecules. She has also worked in a Global Regulatory Affairs and Quality role for the post-approval of biologics.
Previously, Dr. Molina worked at the Institute of Public Health of Chile (ISP, Chilean FDA) and held CMC roles in the biopharmaceutical industry, including several Senior GMP-related roles including Formulation, Process Development and Product Development at where she also performed as Subject Matter Expert (SME) in support to pre-INDs, INDs/CTAs, and NDAs/BLAs/MAAs. She has also consulted Biotech companies advising in requirements and interpretation of applicable global regulations and guidance (FDA/EMA/MHRA/ICH/WHO/LATAM Health Authorities).
Revolutionizing the CGMP DI system development to empower the end users.
Streamline compliance through Single Validation innovation.
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