BA Project Management
We assure that your bioanalytical data have been generated with the least regulatory risk possible, on time and on budget.
BA Forensic Auditing
The help you need, when you need it, from the experts who know how to get the job done.
Drug Development
Stubbs & Hensel can recruit the right people to manage your drug development project.
DRUG DEVELOPMENT SERVICES
Stubbs & Hensel will lead your virtual Drug Development program. An example of one of our current projects:
- Stubbs & Hensel is currently working in a virtual drug development environment with a small start-up client.
- This is a virtual team that serves as the drug development leadership team for our client.
- This team primarily meets once a week, but more often as issues arise
- Stubbs & Hensel has oversight for the bioanalytical work at CROs in support of the entire preclinical and clinical program
- We are working in collaboration with Toxicology, Clinical, CMC, Regulatory Affairs, and Technical writing experts in taking this drug through IND and NDA filings in the US and potential international filings.
- We are reviewing scientific data and editing filing documents
- All bioanalytical work is being run at CROs, and Stubbs & Hensel have total responsibility for this work in addition to providing a GLP audit on behalf of the client to ensure compliance for the preclinical program.
- Stubbs & Hensel manages the technical aspects of this work with the CRO
- We review and sign off on validation protocols on behalf of the client,
- We review all study data, and provide summaries of validation and study data for all regulatory submissions.