PRARD

Professionals for Regulatory Affairs and Research & Development

We prepare and submit following applications of pharmaceutical drug substances, intermediates, and excipients for your chemical, biological, and cell/gene products.

JAPAN

Master File

Initial Registration, Change Notification, Change Registration Application
GMP Inspection by PMDA
MAA Review by PMDA
Foreign Manufacturer Accreditation (FMA)

the United States

Drug Master File (DMF)

Initial Submission, Amendment, Annual Report
DMF Agent、IND/NDA/BLA Review by FDA
Electronic Submission via FDA ESG

ESG: Electronic Submission Gateway

European Union

Active Substance Master File (ASMF)

New Registration, Variation
MAA Review by EMA
Submission via EMA eSubmission Gateway

Certificate of Suitability of European Pharmacopoeia (CEP)

New Application, Review by EDQM
Revision, Renewal
Electronic Submission via CESP

CESP: Commission European Submission Portal
MMA: Marketing Authorization Application

We also provide following services according to clients' requests.

Pre-submission Gap Analysis
Local Agent/Contact for communications with PMDA and Japanese customers
Providing Updated Japanese Regulatory Information

Please contact us: