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.

Changes are a fact of life - and of #clinicaltrial design. But that doesn't mean planning and budgeting for your tr… https://t.co/BUPFjuIXOt
Bioclinica (Yesterday)
Bioclinica announced today that the company has contributed data to the primary efficacy endpoint in more than 200… https://t.co/8epFHqKFcL
Bioclinica (6 days ago)
No change order fees for new clients with our #RTSM platform means fewer hurdles as you race to study start. Ready… https://t.co/Z5AOtkWT3e
Bioclinica (2 weeks ago)
With over 25 years of experience in Cardiac Safety monitoring services, Bioclinica is a recognized global leader in… https://t.co/CMY48C4QVR
Bioclinica (2 weeks ago)
Bioclinica is an agile organization with more 2,300 colleagues around the globe - and growing! Learn more here.… https://t.co/oLPRURkhm7
Bioclinica (3 weeks ago)
Going to DIA Japan in Toyko? Meet our team at booth 47! https://t.co/X1jTu0UbUb https://t.co/vwKvUUbarp
Bioclinica (4 weeks ago)