• 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