Validated capability from Product Development to GMP-approved Commercial Manufacturing

Research and Development

  • Integrated R&D validated through to commercial manufacturing
  • Full-service capabilities for even the most complex product creation
  • In-house regulatory affairs team with proven global track record
  • Flexible Business Model customized to fit your program

Precision Particle Fabrication®

One such novel drug-delivery system is Adare’s Precision Particle Fabrication® technology, which produces uniform microspheres and microcapsules offering precise control over particle structure.

Capabilities

  • Pre-formulation
  • Formulation development
  • Support including physical characterization
  • Analytical Method Development & Validation
  • IMPD Manufacture and QP release
  • Tech Transfer
  • ICH stability programs at all conditions
  • Efficient product development pathways for ANDA, 505(b)(2), IND/NDAs, and novel delivery systems
  • Preclinical to clinical to commercial capability
  • IVIVC-based modified release dosage form development

Speak With An Expert

Profile Photo: Giovanni Ortenzi

Giovanni Ortenzi

Vice President, Pharmaceutical Development & Chief Technical Officer

Giovanni leads our global pharmaceutical development, technical services and operational excellence teams. He was previously Vice President, Quality at Adare leading quality assurance, quality control, clinical quality assurance and compliance teams. Prior to that, he led the quality teams at Aptalis Pharmaceutical Technologies. Giovanni held leading positions at Eurand, including Industrial Operations Director–Europe. He also formerly held quality and manufacturing positions with Bristol-Myers Squibb.

Giovanni holds degrees in Pharmaceutical Chemistry and Pharmacy from the University La Sapienza in Rome, Italy.

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