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.

Come talk to #Bioclinica at #ASCO19! See why we're the world leader in #oncology imaging, helping to assess efficac… https://t.co/h0ng6StIbU
Bioclinica (11 hours ago)
Great insights for sponsors conducting #NAFLD #NASH #clinical trials. https://t.co/TG1WwRhVE8 https://t.co/US2Iobjoyd
Bioclinica (Yesterday)
Visit us at @DrugInfoAssn's DIA China to learn how Bioclinica's science & technology expertise can advance the deve… https://t.co/r4822CjVvv
Bioclinica (3 days ago)
Come talk to Bioclinica at #ASCO19! See why we're the world leader in #oncology imaging, helping to assess efficacy… https://t.co/MyomMS0Rvt
Bioclinica (6 days ago)
Great insights for sponsors conducting #NAFLD #NASH #clinicaltrials. https://t.co/TG1WwRhVE8
Bioclinica (1 week ago)
In Beijing for DIA China next week? If so, drop by Bioclinica's exhibit or catch our talk in the Randomization & Cl… https://t.co/LCNpNHabo2
Bioclinica (2 weeks ago)

Latest Blogs:

Medical Imaging of Non-Alcoholic Fatty Liver Diseases in Clinical Trials
EDC Provider Selection
Site Payments Solutions
Nonalcoholic steatohepatitis (NASH) development programs
Dr. Joby John
Transformational Trends in Investigator Site Payments
Clinical Supply Chain Success: Leveraging Technology
Blood pressure monitor
Prescription box