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