IND Management
The complexity of preclinical and CMC development is not always well understood and this under-appreciation all too often results in toxicology, formulation, and analytical problems arising at the most inconvenient times. We design and manage complete preclinical, CMC and product development programs for virtual biotech and mid-size pharma companies. We provide the expertise and infrastructure of a big pharma R&D group without their bureaucracy and overhead. Using our strategic planning system we develop a complete IND enabling program.
Keys to Success
- IND filing ready within 16 months
- Vendor selection and management
- Budget planning, management, and control
- Project leadership
- Sufficient, relevant, accurate
and consistent information to
all stakeholders throughout
life of project - Interface with TOX/GLP & Clinical sites
- Regulatory and publishing services available