- 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
