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Regulatory Consulting/Support

Providing assistance throughout the development, approval, and post-approval stages of a product's lifecycle.

  • Global Regulatory and Safety Strategy Development Review and Assessment
  • Quality and Regulatory Compliance Audits and Training
  • Identification, Inspection and Due Diligence
  • Reviewing and Assessing Clinical and BE Study Protocols
  • CMC, non-Clinical, Clinical Data Review
  • Gap Analysis
  • Liaison Services with Global Regulatory Agencies
  • Translation of Technical Documents Dossier Management
  • Project Management
Regulatory Consulting/Support

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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.

Bioclinica announced today that the company has contributed data to the primary efficacy endpoint in more than 200… https://t.co/8epFHqKFcL
Bioclinica (3 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 (5 days ago)
With over 25 years of experience in Cardiac Safety monitoring services, Bioclinica is a recognized global leader in… https://t.co/CMY48C4QVR
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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 (3 weeks ago)
Do you know what to ask before choosing your Electronic Data Capture provider? #edc #clinicaltrials #bioclinica… https://t.co/A64WbN9GOC
Bioclinica (4 weeks ago)