Clinical Trial Oral Drug Delivery Services

Enteris BioPharma provides turn-key clinical trial manufacturing services to support our partners’ research and development needs. Our services include supply of GMP clinical trial material, analytical development, and stability testing, with a proven enteric-coated tablet formulation that is scalable and readily transferable.

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   Clinical Trial Manufacturing Offerings

GMP Manufacture of Tablets and Capsules

  • cGMP manufacturing facility
  • Provision of clinical trial materials for US, EU, and globally
  • Equipped to manufacture and package tablets and capsules from bench scale to Phase 2
    clinical trial materials
  • Capable of working with low dose / high potency APIs
  • Experience with technology transfer and scale-up with multiple CMOs

Analytical Development

  • Analytical assay development and validation
    • Evolutionary approach: phase-appropriate through NDA quality validations
    • Submission quality reports
  • On-site in-process control, release and stability testing
  • Full support through analytical method transfer

Quality Systems

  • Systems compliant with FDA, EMA and ICH
  • Customer focused, providing real time feedback on all quality related issues
  • Full project participation:
    • Process development → batch record design → GMP manufacture
  • Manufacturing oversight through concurrent batch record review
  • Label control for blinded and open-label studies
  • Vendor auditing and qualification program