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Regulatory Services

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.
Regulatory 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)