Consulting to the Pharmaceutical Industry
STRATEGIC
REGULATORY
TECHNICAL


Our Work Product

INDs

Investigational New Drug Applications

NDAs

New Drug Applications

ANDAs

Abbreviated New Drug Applications

BLAs

Biologic License Applications

IDEs

Investigational Device Exemptions

[510(k)]s

Premarket Notifications

PMAs

Premarket Approvals

Marketing Applications

Investigator Brochures and Summary Reports


Associated Services


Ancillary Support