Facility Details

We are a team of product development professionals who help institutions and their investigators comply with FDA regulations in the development and manufacturing of investigational products (drugs, biologics, devices) for human clinical trials. Our main work areas are:
- writing quality system documents (e.g., SOPs, Master Batch Records)
- writing IND and IDE applications
- GMP and GLP training programs
- project management for product development
- planning non-clinical studies and placing studies at a CRO
- planning manufacturing and testing programs
- monitoring work at CROs and CMOs
- auditing laboratories and records
- QA review of completed batch records, or of study reports
- planning and management of product stability studies

At our home institution, Memorial Sloan Kettering Cancer Center, we write 5 or more IND applications annually and provide QA services for over 40 manufactured products.

We charge for our work time plus expenses.