Investigational new drug (IND)

New drug application (NDA)

Abbreviated new drug application (ANDA)

Authoring of annual reports, drug master files, dossier amendments and supplements

Preparation of electronic common technical documents (eCTD) applications

Scientific/project-specific site visits

GMP audits to evaluate vendor staff and facility capabilities necessary to execute your program

Interpretation of scientific results

Advice on setting appropriate specifications, assigning product shelf life and conducting failure investigations

Project management services