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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.

As #clinicaltrial designs evolve, trial supply management becomes increasingly complex. Adaptive protocols, direct-… https://t.co/cQa00yp9hi
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#CTMS is integral to #clinicaltrials, but it can be resource-intensive. That's why we created Bioclinica CTMS Direc… https://t.co/pW9ySieiE2
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Going to SCOPE? Visit Bioclinica at booth 404! #SCOPE2020 https://t.co/MuzWXHoC2y https://t.co/mpveryx7Xs
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In case you missed it: Bioclinica announces additions to Software Solutions leadership. We welcome Guy Crossley, Ri… https://t.co/8VWOO3IPFD
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Meet Chief Science Officer, Thomas Fuerst, Ph.D., to learn more about our musculoskeletal imaging services.… https://t.co/QFQ1HSV4uV
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