We Offer :
- - Module 2.4 Nonclinical Overview
- - Module 2.5 Clinical Overview
- - Module 2.6 Nonclinical Summary
- - Module 2.7 Clinical Summary
Also we can review the contents of Module 4.0 and 5.0 to be compiled in the CTD.
- info@eminent-bioservices.com
- New Delhi and Mumbai
Medical Writing
Scope
We are providing Medical Writing services to complete the dossier. We have team with expertise in writing the CTD modules and process the deficiency letters from the authority to complete the market authorization process.
We are also providing Medical Writing services for Risk management plan (RMP). We have team with expertise in writing the RMPs and process the deficiency letters.
We Offer following RMPs in compliance with regulatory requirements:
- - New active substance
- - Similar biological
- - Informed consent
- - Generic medicine
- - Hybrid medicinal products
- - Fixed combination
- - Well established use
- - Same active substance