Cusp PharmaTech Consulting LLC (CUSP) enables the efficient translation of a promising drug from the discovery laboratory to the marketplace.

1. •Mark Staples (via CUSP) assists with any tasks that support the Chemistry, Manufacturing and Controls (CMC) section of Regulatory submissions, in particular Investigational New Drug (IND) and New Drug Applications (NDA).
   

2. Access Mark’s extensive expertise in these functions:
   

3. •    Pharmaceutical Science
   

4. •    Analytical Methods
   

5. •    Process Development
   

6. •    Regulatory (CMC Section)
   

7. •    Management
   

8. •CUSP tailors its services to the needs and interests of its clients, whether they are start-up, clinical development, or commercial organizations in the pharmaceutical or biotechnology industries.
   

9. •CUSP has experience with a wide range of product types in the drug and biologic categories, including small molecules, peptides, proteins and combination products.
   

10. •CUSP applies a broad range of approaches to fit project requirements, for example: advising hands-on at the bench level, participating in teleconferences, assisting with audits, compiling and writing sections of regulatory submissions or reports, and managing a network of vendors.