Expert reports and medical writings


With a broad base of doctors and experts in our company, we offer various expert reports and medical writings.

 

Expert reports and preparing of CTD dossier:

  • Rx to OTC Switch Report
  • Comprehensive ensure of CTD Modules 2, 4 and 5
  • Ensure CTD Module 1 and 3 in cooperation with applicant
  • Clinical Overview – CTD module 2.5
  • Clinical Summary - CTD module 2.7
  • Non-clinical Overview - CTD module 2.4
  • Non-clinical Summary- CTD module 2.6
  • Quality Overall Summary - CTD module 2.3
  • Risk-benefit evaluation - Statement of the Clinical Expert  
  • Answers to Deficiency Letters of DRAs
  • Evaluation of the preclinical and clinical part of the documentation (license products audit)
  • Preparation of comparison table for submission (based on local texts provided by the client)
  • Correction of texts during the procedure (upon DRAs requests) and preparation of response tables
  • Preparation of corrected texts for variations
  • Revision of registration dossier, analysis and evaluation of registration strategy

 

Drug Development Support

  • Support drug development projects regarding clinical issues and Medical Regulatory Strategies.
  • Market analysis and forecast of its development

 

Marketing Supporting Material:

  • Product Manual - complete evaluation of the available literature data in structured format
  • Thematic analysis and literature comparative studies
  • Preparation of information materials based on available literature
  • Preparation of publications and marketing publications 
  • Revision of marketing publications

 

If you are interested in detail information or price offer, please contact us by email on This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

 

Are you also interested in regulatory affairs, patents or literature search?