Easington Pty Ltd

  • Product Development

Easington specialises in providing strategic and operational services to biopharmaceutical and medtech companies with products in preclinical and clinical development. We offer a wide range of product development services tailored specifically to the needs of small companies, including:

  • Regulatory and clinical strategies and plans for new chemical/biological entities and medtech products
  • Defining Target Product Profiles, including specification development and stability programs
  • Preclinical consulting and design of preclinical development programs
  • Integrated clinical trial planning
  • Chemistry, manufacturing and control (CMC) consulting.
  • Establishing contract manufacturing and analytical services
  • Project management of multidisciplinary project teams
  • Medical writing, including information packages, investigator brochures, clinical study protocols and reports including clinical evaluation reports for Medtech
  • Review of preclinical study protocols and draft reports
  • Preparation of pharmaco-toxicological expert reports
  • Independent safety evaluations to support applications to Independent Review Boards and Ethics Committees
  • Regulatory submissions
  • Clinical project management
  • Liaison with data management organisations and other third-party providers
  • Monitoring of clinical studies
  • Establishing & maintaining Quality Systems for Therapeutic Goods manufacture (GMP, ISO 13485)
  • Supplier/Contractor evaluation and compliance audits

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