Please Wait...

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

LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
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.

Integration of #eTMF and #CTMS eliminates redundancies, improves workflows & enables greater study control. Join th… https://t.co/1917MtlAsA
Bioclinica (4 days ago)
Thinking of building a study in-house? Here are the 5 things you should think about before starting a DIY study bui… https://t.co/xzZWQOm49S
Bioclinica (2 weeks ago)
Integration of #eTMF and #CTMS eliminates redundancies, improves workflows & enables greater study control. Join th… https://t.co/Hoqf18zcPF
Bioclinica (2 weeks ago)
Your #IRT should not be the limiting factor during study start-up. The core features of Bioclinica's IRT agile plat… https://t.co/kitdsWvJ2S
Bioclinica (2 weeks ago)
Presenting Bioclinica CTMS: a rapid startup #CTMS that takes 2 weeks to implement, rather than months. Bioclinica C… https://t.co/tclYFoJx2z
Bioclinica (3 weeks ago)
Improve doc & study mgmt. across all studies by integrating #eTMF & #CTMS. In this webinar, Bioclinica &… https://t.co/UyoQyJVDah
Bioclinica (3 weeks ago)