GB Pharma Group

  • Interventional studies Phase I and Phase II-IV
  • Non Interventional Studies (NIS): Observational Registry (OBS), Epidemiological (EPI), Outcome Research (OR) also for Market Access
  • Regulatory Studies (PASS, PAES)
  • Project Management & Monitoring
  • e-CRF / Data Management & Statistics
  • Pharmacovigilance in Clinical Trials
  • Medical Writing
  • QA, GCP & GVP Audit
  • Vendor selection and audit (GMP, GLP)
  • Regulatory Affairs:
    • Pre-Authorisation Activities for National and European registration
    • Post-Authorisation Activities for National and European registration
  • Orphan Drug (Development, Authoriazation and Maintenance)
  • Pharmamcovigilance Post-Marketing
  • Market Access Projects
  • Business & Marketing Strategies:
    • Licensing In and Out
    • Due Diligence and Audit
    • Portfolio Evaluation
  • Interventional Trials (Phase II- IV)
  • NIS (registry, PASS, epidemiologic, observational, PRO)
  • Phase I Studies and bioequivalence
  • Clinical Research services (from medical writing to data management, stats and EDC)
  • Medical Writing
  • Regulatory Affairs
  • Pharmacovigliance
  • Toxicology

3B Biotech Research