Successful regulatory strategy and its implementation is critical for a successful project and health authority application while saving significant amount of time and money for your organization. Western BioPharma’s regulatory team is composed of senior BioPharmaceutical regulatory experts. Western can be your best regulatory partner and can offer diverse portfolio of services.
ANDA Pathway
US FDA Agent Service
Regulatory Strategy and Guidance on Required Data for Submission and Timelines
Regulatory Gap Analysis
ANDA Dossier Preparation and Review
FDA Interactions & Meetings
Post Approval Changes and Supplements
Life Cycle Management
Annual Reports
NDA & BLA Pathway
US FDA Agent Service
Phase Specific Regulatory Strategy and Guidance
Regulatory Gap Assessment
IND Enabling Support
Regulatory Writing/Dossier Preparation for IND, NDA (505b1 and 505b2), and BLA.
Agency Meeting (Type A, B - preIND, EoP, preNDA and Type C) Requests and Briefing Books
Fast Track, Break Through, Orphan, RMAT Designation Requests.
Post Approval Changes, and Supplements
Annual Reports/DSUR, PADER, and PSP
Adverse Event Reporting to FDA
DMF Preparation & Submission Support
Conversion of IND to CTA (EU or Health Canada)
Conversion of NDA to MAA (EU) or NDS (Health Canada)
