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Regulatory Global Submissions

Bioclinica works with our clients throughout the development, MA approval, and post-approval (variations, updates, notifications, etc.) phases by helping prepare, submit, and follow-up on all submission content to applicable regulatory bodies. We have extensive knowledge of national and international standards which ensures an efficient process to bring products through approval and to market.

  • Abridged Applications, ANDA, OTC, health supplements, complementary medicines application submissions
  • Marketing Authorization Applications
  • Filing Variation IA, IB and Type II through MRP, DCP or National Procedures
  • Renewal Applications
  • Global Clinical Trial Applications Phase I to Phase IV
  • Medical Devices Dossier Submissions
  • Dossier filing through MRP, DCP and National procedures
  • Managing Product Life Cycle throughout its shelf-life
  • Import and Export License applications (Clinical trial Drugs, Biological Samples)
Regulatory Global Submissions

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Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

Bioclinica’s Joby John reflects on the #SCDM2018 Annual Conference & being a part a thriving community of clinical… https://t.co/c70gH5kJo9
bioclinica (12 hours ago)
RT @bioclinica: Our own Jeff Heilbraun is in Tokyo nxt wk to lead a discussion at DIA’s Cardiac Safety Workshop in Japan. Jeff will give an…
bioclinica (17 hours ago)
RT @Xtalks: Trends in #SitePayments: Insight into How CROs Can Gain a Competitive Edge This webinar will focus on the latest market researc…
bioclinica (17 hours ago)
Great connecting w @bioclinica clients Odonate Therapeutics, Eisai, & PCI Biotech, at #ESMO18 #oncology… https://t.co/4wKrLof8e6
bioclinica (19 hours ago)
Our own Jeff Heilbraun is in Tokyo nxt wk to lead a discussion at DIA’s Cardiac Safety Workshop in Japan. Jeff will… https://t.co/BX6wzXctMm
bioclinica (3 days ago)
Let's talk oncology clinical trials at #ESMO18 ! Tap the knowledge of medical & scientific experts @bioclinica who'… https://t.co/RlTjGND5Qg
bioclinica (4 days ago)

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