
Our services
Regulatory Affairs Consulting
Abbreviated New Drug Application(ANDA)
Administrative
- Form FDA-356h Review
- Form FDA-3794: GDUFA Cover Sheet Form Review
- FDA-3674: Certification of Compliance Review
- Table of Content Review
- Certifications Review
- Environmental Impact Analysis Review
eCTD Summaries
- Quality Overall Summary (QOS) (Drug Substance and Drug Product)
- Clinical Summary – (In vitro Binding Studies, Clinical and PD Endpoints, Biopharmaceutics Classification System)
Quality
- Chemistry Manufacturing and Controls Review
- Drug Product Review
Clinical Studies Report
- BA/BE Content Review
Our brands and projects




