Are you a start-up pharmaceutical company but don't need a full time regulatory affairs department?Do you need additional resources to supplement your regulatory group for a special project?Do you need expertise to guide and shepherd your drugs across the
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RegRx Consulting, LLC - Home | regrxconsulting.com Reviews
https://regrxconsulting.com
Are you a start-up pharmaceutical company but don't need a full time regulatory affairs department?Do you need additional resources to supplement your regulatory group for a special project?Do you need expertise to guide and shepherd your drugs across the
regrxconsulting.com
RegRx Consulting, LLC - Services
http://www.regrxconsulting.com/services
RegRx Consulting, LLC. At RegRx Consulting, LLC, we treat your products like they were our own. Drug Regulatory Affairs Services. Overall regulatory development strategy. Interactions with FDA and other regulatory authorities. Negotiating labeling with FDA. Maintaining INDs during development. Maintaining NDAs post approval. Review of advertising and promotional campaigns including new product launches. Review of press releases. Management of OIG/PhRMA Code compliance. New Drug Applications (NDA).
RegRx Consulting, LLC - Home
http://www.regrxconsulting.com/home
RegRx Consulting, LLC. Are you a start-up pharmaceutical company but dont need a full time regulatory affairs department? Do you need additional resources to supplement your regulatory group for a special project? Do you need expertise to guide and shepherd your drugs across the myriad regulatory hurdles? RegRx Consulting, LLC provides consulting services to US and foreign pharmaceutical companies who need assistance with development and commercial drug regulatory affairs.
RegRx Consulting, LLC - About Us
http://www.regrxconsulting.com/about_us
RegRx Consulting, LLC. RegRx Consulting, LLC. Is a select group of highly skilled regulatory affairs professionals with over 50 years of combined experience with the US FDA (CDER/CBER) and other regulatory authorities. We provide consulting services and solutions to US and foreign pharmaceutical companies who need assistance with development and commercial drug regulatory affairs. Roberta (Robbie) Tucker and Elizabeth (Liz) Fenna are partners of RegRx Consulting, LLC.
RegRx Consulting, LLC - Our Blog
http://www.regrxconsulting.com/our_blog
RegRx Consulting, LLC. Check out our weekly blog on all things regulatory every Wednesday. We hope you enjoy it! PDUFA V Adds Two Months to the Review of NDAs and BLAs. June 1, 2012. Two more months have been added to the clock meaning FDA that FDA will have 12-14 months for the review of NDAs and BLAs and 8 months for the review of priority submissions. PDUFA V must be approved before September 30. Plaque in the News. The PLAGUE rare and. Can you only imagine the Informed Consent for a human study?
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RegRx Consulting, LLC - Home
RegRx Consulting, LLC. Are you a start-up pharmaceutical company but dont need a full time regulatory affairs department? Do you need additional resources to supplement your regulatory group for a special project? Do you need expertise to guide and shepherd your drugs across the myriad regulatory hurdles? RegRx Consulting, LLC provides consulting services to US and foreign pharmaceutical companies who need assistance with development and commercial drug regulatory affairs.
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