– Replacin Pvt. Ltd. , offer pharma regulatory services to strengthen our clients dossier submission endeavor to global regulatory agencies.
– Our professionals have developed good understanding of regulatory and scientific guidelines and are able to provide innovative and cost effective solutions to our client’s regulatory needs.
– We support our clients by providing advice and guidance to full spectrum of regulatory requirements of regulated as well as emerging markets to succeed in dossier submission.
– Medical Writing for Regulated Market
Preparation of Expert Report
• Non-Clinical Overview (Module 2.4)
• Clinical Overview (Module 2.5)
• Non-Clinical Overview Summary (Module 2.6)
• Clinical Overview Summary (Module 2.7)
• BCS Biowaiver Monograph (Module 5.3.1.3)
• Patient Information Leaflets (PIL)
• Summary of Product Characteristics (SPC)
• Literature Report
Drug Regulatory Affairs
• Compilation of the Common Technical Document (CTD) sections in eCTD format for Regulatory Agency’s (WHO, Europe and USFDA)
• Preparation, review and Compilation of eCTD Modules for Quality section like;
– Module 2 (Summary of the Pharmaceutical Product).
– Module 3 (Quality of the Pharmaceutical Product)
– Module 4 (Non Clinical studies)
– Module 5 (Clinical studies)
• Preparation for filling strategy for category of application Europe submission like;
– Generic Application 10 (1)
– Hybride Application 10 (3)
– Well Establish Application 10(a)
– BCS Biowaiver Application