Consulting

Certara's scientific consultants support strategic drug development decisions and submission-ready analyses.

Pharsight Consulting Services

Covering the Spectrum

From Discovery through Development

Videos

Introduction to Certara Consulting Services - helping 13 new drugs get approved in the last two years

Latest Tweets

Bookmark and Share

Medical Writing

Reporting and Regulatory Medical Writing Services

Pharsight Consulting Services provides a full range of regulatory report writing services that reduce your risk of delays and increase your probability of success with regulatory submissions.

For more than 15 years, Pharsight scientists have helped clients understand, determine and quantitatively support dosing decisions.  We have extended that expertise into Medical Writing services, so that the dosing rationale is clear and well understood by regulatory reviewers. We generate the following regulatory-compliant reports and common technical documents (CTD) that focus on the important clinical and pharmacological messages that impact dosing and labeling:

PK/PD, Efficacy, Safety and Tolerability Reporting (CTD Modules 4 and 5)

  • Pre-clinical (GLP)
  • Noncompartmental, compartmental and population PK/PD analyses
  • ICHE3 Clinical Study Report (CSR)
  • Patient narratives

Overview and Summaries for NDA Submission (Module 2)

  • Module 2.4 and 2.6: Pre-clinical Overview and Detailed Summaries
  • Module 2.5: Clinical Overview
  • Module 2.7.1: Summary of Biopharmaceutical data
  • Module 2.7.2: Summary of PK/PD
  • Module 2.7.3: Summary of Efficacy Data
  • Module 2.7.4: Summary of Safety Data

Benefits of Working with Our Medical Writing Team

  • Regulatory Compliant Environment:  Documented quality control processes and application of ICH, regulatory guidelines
  • Increase Your Production Capacity: Flexibility to follow client-specific SOPs, customized documents and style guides; consistency in data presentation
  • Provide Clear Communication of Dosing Rationale:  Avoid delays and prolonged regulatory review cycles.