Services

 

Finis origine pendet (The end depends on the beginning)

                                                          Attributed to Roman poet Manlius

Document Strategies

MedWrite, Inc. writes regulatory documents and develops document strategies for submissions for the pharmaceutical, biotechnology, and medical device industries.

A ‘targeted’ approach to writing is used, in which content is managed for consistency, accuracy, and support of key messages across all documents and submissions.

Product Classifications

  • Pharmaceuticals
  • Medical devices
  • Biologics
  • Combination products
  • Vaccines

Submissions

  • Investigational New Drug Applications (IND)
  • New Drug Applications (NDA)
  • Biologics License Applications (BLA)
  • Investigational Device Exemptions (IDE)
  • Premarket Approval Applications (PMA)
  • Marketing Authorisation Applications (MAA)
  • Investigational Medicinal Products Dossiers (IMPD)

Documents

  • Clinical protocols
  • Clinical study reports (CSR)
  • Investigator’s Brochures (IB)
  • Integrated summaries of  safety and efficacy (ISS and ISE)
  • Nonclinical study reports
  • Nonclinical integrated  summaries of multiple studies
  • Package inserts
  • Directions for Use

Tools

  • Style guides
  • Templates