Services
- Contractor evaluation and selection
- IND/NDA strategy and work plans
- Technical project management to assure that:
- Possible problems are found early so they can be solved quickly
- Information is integrated across all contractors and within the company
- Projects delays are minimized and known in advance
- Possible difficulties are identified and back-up plans prepared in advance
- Regulatory needs are identified
- Compile and write CMC section for INDs and NDAs
- “Temporary” highly skilled person to keep a project going in an emergency
- Preparation for due diligence or other examination
- CMC due diligence
Posted by admin on January 24th, 2012