IND-enabling Project Management Services
Oversight by the Sponsor biotech company of external vendors is essential to keeping your projects on track. Our Project Managers can ensure that your timeline and budget are being met and quality is maintained by your vendors.
We provide Project Managers who understand the process and risks of product development, can prepare and communicate a project plan, put into place risk mitigation plans and lead a project team of external vendors. This is critical to minimizing problems and delays of your product development.
Adding an experienced Project Manager to your team is a value added strategy. While this may be an added cost up-front, the cost of fixing problems after the event and recovering lost time can be the difference between a project that succeeds and one that does not.
Project Manager Resources:
- Act as internal company resource to oversee project and pivotal point of contact
- Prepare Project Plan and budget
- Identify external contractors (manufacture/testing, preclinical pharm/tox)
- Provide oversight and management of vendors
- Facilitate information and methods transfer
- Monitor of project resources, tasks and timeline
- Provide project updates and reports when needed
Additional IND-enabling Resources:
- Toxicology Consultants
- CMC consultants (biologic and small molecule)
- Regulatory consultants (including device advice)