Experienced, Biopharma and Biomedical Science Consulting
Sleeping Giant Biopharma Consutling
Our Experience
15+ years of translational research and bioanalytics experience in biotech, non-profit and pharma.
Ability to quickly come into late-stage preclinical programs and cultivate these programs toward the clinic from the experimental biology, pharmacology, safety and regulatory perspectives.
Our Expertise
- Preclinical Development: Translational, Molecular, and Cellular Research.
- Experimental Biology: Bioanalytics, Informatics, Data Analysis, In Vivo Studies, and Biomarker Identification.
- Grant writing: R01, R21, SBIR / STTR and private foundation grants.
- Support regulatory affairs activities by preparing, reviewing and completing submission ready pharmacology, DMPK and toxicology study reports, IND, BLA and NDA sections as well as composing other FDA-correspondences and requests (DSUR, CSR, IB, RMAT, RFD, etc).
- Create publication ready manuscripts for completed clinical studies, interfacing with non-clinical and clinical departments, biostatistics and external collaborators as necessary.