11 Coventry Ln,
Stoneham, MA 02180

NDA/BLA Filing

NDA/BLA Filing

You have successfully completed early-phase and late-phase clinical studies after significant investment. XP Pharma Consulting works with you to prepare clinical pharmacology portions of NDA/BLA submission documents, conduct necessary pooled analysis, and response to regulatory questions. We offer following services:

Regulatory Writing and Strategy

  • Authoring CTD m.2.7.1, m.2.7.2 and key contributor to m2.5 (biopharmaceutics, clinical pharmacology, dose justification) and certain sections of m2.7.3 and m2.7.4
  • Author PK and PD sections of the label
  • Integrated PK and PK/PD analyses and reports
  • Integrated immunogenicity analyses and reports
  • Responses to questions in the review period post submission
  • Regulatory representation
  • Ad hoc PK/PD analyses
  • Manuscripts, posters, conference presentations

Ad-Hoc PK/PD Analyses

  • Integrated immunogenicity analyses, data interpretation and reporting.
  • Pooled PK/PD analyses, results interpretation and reporting.
  • Integrated risk assessment for QT prolongation.

Regulatory Interactions

  • Interpret regulatory questions.
  • Conduct ad-hoc PK/PD and E-R analyses as needed to address questions.
  • Responses to questions during review period
  • Representation at regulatory meetings
Submit a Request for Proposal (RFP)

© Copyright 2024. All Right Reserved.