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Dan Fishelovitch

Dan Fishelovitch

Executive CMC management and consulting

Israel

I am a passionate CMC expert, expereinced in all drug development stages, CMC R&D, Quality, and Regulatory wise, that is driven by saving lives and improving patients quality-of-life.

I have 14 years of experience in the pharmaceutical industry working in several companies in R&D and CMC managerial roles.
The below are my main fields of expertise:

• Formulation development - OSD: IR, DR, ER, oral solutions, injectables, lyophilized products, eye drops,
Drug-Device combination products, ATMPs
• Process development: design, characterization, scale-up, optimization, validation, QbD concept
implementation
• Granulation, capsulation, tablet compression, beads and tablet coating
• Clean rooms, aseptic manufacturing, sterile filtration, terminal sterilization
• GMP manufacturing & QMS
• Small molecules, peptides & proteins, cell-based ATMPs
• CRO/CMO/CDMO selection and management for DS and DP
• CMC RA writing: CTA, IND, SA, MAA, NDA, BLA
• Actively support regulatory filing of clinical trial applications and other regulatory submissions and
consultations (EMEA, FDA, and locals such as PEI, BfArM, MHRA, Israel MOH)
• Project management: budget, timelines and risks
• Chain supply management

I am open to providing services


Experience:

  • Head of CMC (Enlivex Therapeutics (Nasdaq: ENLV))
  • CMC project leader (Teva Pharmaceuticals)
  • CMC director (Mitoconix Bio)
  • Head of CMC (NeuroDerm, A Mitsubishi Tanabe Pharma Group Company)
  • CMC manager (Neuroderm)
  • Senior Project Manager (Neuroderm)

Skills:

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