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