Consultations with extensive regulatory experience

Our consulting services include:

Regulatory

• Regulatory strategy for product development

• Regulatory dossier writing for INDs and NDA/BLAs including clinical and nonclinical

• Regulatory dossier reviews for INDs and NDA/BLAs

• Lead FDA face to face meetings

• Expedited pathway guidance: Fast track, Breakthrough Therapy, Orphan Drug Destination (ODD)

• eCTD formatting, publishing and submission

• Due-diligence services for investors

Clinical

• Phase-specific nonclinical program strategy guidance and gap assessment

• Study proposal and GLP study protocol review

• Study report review, results interpretation

• Study report composition in compliance with FDA guidance PK/PD modeling

• Generation of simplified TS data set for toxicology studies

• IB preparation (clinical section)

• Clinical study report translation

Biostatistics

• Go/No Go Decision

• Study Design and Protocol Development

• Statistical Analysis Plan and Report(SAP and SAR)

• USFDA/EMA/NMPA, etc. submission

• PK/PD data analysis and modeling

• Exploratory analysis

• Real world data

• IDMC independent statistician