Focused expertise in all facets of drug development
From discovery and planning all the way through regulatory, we support small biotech’s with complete and comprehensive drug development — delivering the strategy, team and roadmap clients need to be successful.
- We create efficiencies by knowing just how to navigate each phase of drug development
- We help companies with limited budgets maximize resources and create value
- We rely on a team – 150 associates who satisfy every niche of virtual drug development
- We provide expert advice steeped in real-world drug development experience
- We work hands-on to achieve desired biological outcomes
- We can provide a full team or simply the individual expert needed which makes us ready from day one
Designing and implementing a comprehensive drug development program.
Yes, we can do that.
- Medicinal chemistry
- Lead optimization
- Target product profile
- Defining the program
- Outlining non-clinical, clinical and regulatory strategies
- Developing a timeline and budget
- Identifying vendor(s)
- Developing scalable synthesis route
- Analytical method development
- GMP manufacturing
- Dosage form selection
- Formulation development
- Analytical development
- GMP manufacturing
- Disposition, Metabolism, and Pharmacokinetics (DMPK)
- Non-clinical pharmacology
- Safety pharmacology
- Toxicology
- Regulatory strategy
- Pre-IND meeting and briefing book
- IND (and/or IMPD) preparation and filing
- Program leadership
- Project management
