Regulatory Professionals, Inc.

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Description

  • 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 FDAs 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/
  • location

    Headquarters:8000 Jarvis Avenue Suite 100, Newark, California, United States

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  • Regulatory Professionals, Inc. phone

    Phone Number: +1 408-263-6861

  • Regulatory Professionals, Inc. website

    Website: https://www.regprofessional.com

  • Regulatory Professionals, Inc. employees

    Employees:42

  • Regulatory Professionals, Inc. revenue

    Revenue:$10 - 50M

  • Regulatory Professionals, Inc. legal name

    Legal Name:Regulatory Professionals, Inc.

  • Regulatory Professionals, Inc.'s Social Media

    Regulatory Professionals, Inc. linkedin
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  • |  NAICS Code: 446110  |

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Vice President for Regulatory Professionals, Inc.

Zhengyu Liu

Vice President

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View Employees

Zhengyu Liu

Vice President

Aurora Sosa

Vice President Regulatory Affairs

Laura Kilgore

Vice President, Regulatory Affairs Cmc

Kristi Miller

Senior Vice President

Scott Winram

Senior Director Of Program Management

Frequently Asked Questions regarding Regulatory Professionals, Inc.

  • Where are Regulatory Professionals, Inc.'s Headquarters?

    Regulatory Professionals, Inc.'s Headquarters are in 8000 Jarvis Avenue Suite 100,Newark,California,United States

  • What is Regulatory Professionals, Inc.'s phone number?

    Regulatory Professionals, Inc.'s phone number is +1 408-263-6861

  • What is Regulatory Professionals, Inc.'s official website?

    Regulatory Professionals, Inc.'s official website is https://www.regprofessional.com

  • What is Regulatory Professionals, Inc.'s Revenue?

    Regulatory Professionals, Inc.'s revenue is $10 - 50M

  • What is Regulatory Professionals, Inc.'s NAICS code?

    Regulatory Professionals, Inc.'s NAICS code is 446110

  • How many employees are working in Regulatory Professionals, Inc.

    Regulatory Professionals, Inc. has 42 employees

  • What is Regulatory Professionals, Inc.'s Industry?

    Regulatory Professionals, Inc. is in the industry of Pharmaceuticals

  • Who is Regulatory Professionals, Inc.'s Vice President?

    Regulatory Professionals, Inc.'s Vice President is Zhengyu Liu

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