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CMC

Regulatory CMC for Biologics / Biopharmaceuticals

By Regulatory Professionals | CMC, White Papers | Comments are Closed | 1 October, 2019 | 0

Learn about Master Cell Bank concerns and other areas of concern. Download the white paper here.Read more

RPI Acquired by Premier Research to Expand Regulatory Offerings

By Regulatory Professionals | News | Comments are Closed | 30 July, 2018 | 2

NEWARK, Calif., JULY 30, 2018 — Regulatory Professionals, Inc., has joined Premier Research, a global provider of clinical development services, in a partnership that will offer regulatory solutions to biotechnology, pharmaceutical, and medical device companies.Read more

Recent Posts

  • Speed vs Safety: How Regulators Are Sizing Up Evidence Today
  • Beware of Underestimating the Value of a Pre-NDA Meeting
  • Outsourcing-Pharma.com: Holistic Approach Benefits Drug Development
  • 5 Tips to Avoid an IND Clinical Hold: Regulatory Guidance and Insights
  • The FDA Is Ending Its Rare Pediatric Disease Priority Review Vouchers – and Time Is Running Out to Get One

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Headquarters

8000 Jarvis Ave.
Suite 100
Newark, CA 94560

North Carolina

One Park Drive, Suite 150
Box 13608
Research Triangle Park,
NC 27709

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Aventine Building
8910 University Center Lane
Suite 400 San Diego, CA 92122

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250 South Oak Way
Green Park
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Ground Floor, 23 Milton Parade
Malvern VIC 3144

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  • About Us
    • Our Story
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  • Services
    • Overview
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    • Electronic Publishing | eCTD Services
    • Medical and Regulatory Writing
    • Quality Assurance
    • Project Management
    • Electronic Trial Master Files (eTMFs)
  • Resources
    • Blog
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