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Victoria Bautista Email
Regulatory Operations Associate II . Regulatory Professionals
Newark, CA
Locationv****************@regprofessional.com
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Regulatory Professionals, Inc. (RPI) specializes in providing strategic and operational regulatory services in all aspects of domestic and international regulatory affairs including clinical, preclinical and CMC development, quality assurance and regulatory writing and has extensive submission experience in FDA's required electronic format (eCTD) with a fully staffed publishing department onsite. RPI has additional expertise in the set up and maintenance of electronic Trial Master Files (eTMF) for clinical studies and preparation of clinical study files for health authority audits. RPI has extensive experience in all therapeutic areas, working as regulatory lead or support for numerous INDs, CTAs, NDAs, BLAs, and MAAs. Products include 505(b)(2) drugs, drug/device combinations, Mabs, therapeutic proteins, cell and gene therapies. RPI can provide the complete regulatory solution, including acting head of regulatory affairs or supplement existing staff in times of high need. We have helped hundreds of sponsors reach their regulatory milestones with a highly personalized approach to our service offering. Visit the RPI Blog today! http://regprofessional.blogspot.com/Regulatory Professionals Address
8000 Jarvis AvenueNewark, CA
United States