Helping clients optimize pharmaceutical development and gain regulatory approval.
Our primary products are strategic development advice and original writing of the technical submission documents. The focus is on clinical and nonclinical development; integration of chemistry, manufacturing, and controls (CMC) information; and regulatory support.
Ancillary services include the production, submission and follow-up of applications, support in data analysis and interpretation, clinical study report writing, clinical trial safety monitoring, and postmarketing surveillance and adverse event reporting.
Our Work Product
Investigational New Drug Applications
New Drug Applications
Abbreviated New Drug Applications
Biologic License Applications
Investigational Device Exemptions
Investigator Brochures and Summary Reports