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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.

ASCPT 2018 Annual Meeting https://t.co/i0mjYbBq5N Join @Bioclinica Research's Open House 3/22 https://t.co/citlLotbD7
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Kevin Bishop, named a 'Top Innovator' in #clinicaltrials by @CenterWatch See how we're reducing risk to the clinic… https://t.co/rXBGvIh9Wr
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RT @CenterWatch: Congratulations to all our #2018TopInovators! Read about the innovations in the #CWMonthly special edition, https://t.co/Y…
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RT @CenterWatch: .@Pfizer demonstrates leadership in #clinicaltrial innovation with two spots on the @CenterWatch #2018TopInnovators, https…
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