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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.

Still time to catch up on summer reading on recent developments in #Alzheimer's Disease Fluid Biomarkers here int t… https://t.co/kyQmz7FxlN
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Our clients have substantial success w #eSource, some spanning well over a decade. Still other organizations remain… https://t.co/UwVs6ajPp4
bioclinica (3 days ago)
Our clients have substantial success w #eSource, some spanning well over a decade. Still some in the industry remai… https://t.co/ASuUvN6xb9
bioclinica (5 days ago)
RT @RfwrightLSL: When Do You Think #BYOD (Bring Your Own Device) Will Become Widely Used To Capture PRO Data In #Clinical #Research? https:…
bioclinica (2 weeks ago)
ICYMI: Our V.P./Head of Neuroscience & Cardiovascular Svcs., Dr. Joyce Suhy, talks about challenges in determining… https://t.co/Lns6B3VPPN
bioclinica (2 weeks ago)
RT @FCR_News_Today: FDA Issues New Guides on Use of Electronic Health Information in #ClinicalTrials. #ClinicalResearch https://t.co/j8LHV2…
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