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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.

Reminder: Today's webinar on Clinical Endpoint Adjudication kicks off at 1 PM Eastern. > https://t.co/1IU9TVFCFA
bioclinica (2 days ago)
In a new go-to-guide on conducting #Alzheimer's clinical trials, @bioclinica experts Joyce Suhy, Marieke Cajal, Luc… https://t.co/SaBFm3L9CL
bioclinica (3 days ago)
Clinical Endpoint Adjudication Webinar. Join us in a live online event this Friday, (6/15) Details & reg. > https://t.co/uBjlgSMnDS
bioclinica (3 days ago)
Clinical Endpoint Adjudication webinar this Friday! Interested in establishing a universal clinical vocabulary to i… https://t.co/uPD992tSaY
bioclinica (4 days ago)
RT @Pints4PDOrlando: Amazingly grateful to @BioclinicaFLA @bioclinica for their super generous donation to @michaeljfoxorg @teamfox in our…
bioclinica (4 days ago)
RT @E_de_Azambuja: ESMO at ASCO2018: please visit booth 5078 if you want more information on ESMO activities and opportunities @myESMO #asc…
bioclinica (2 weeks ago)

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