THIRD PARTY DOSSIER PREPRATION
About the course:-
Providing qualitative Dossier Preparation Service to clients is the principal scenario of this course. Design and implement drug development writing projects specifically tailored to organization and or products. A blend of proven operational methodologies, processes, Standard operating procedures (SOP's), technology, infrastructure, tools, templates and the 'right' kind of human intellect to deliver our projects consistently on time and agreed upon quality guidelines.
Objective of the course:-
THIS PROGRAMME HELPS IN COMPILATION OF DOSSIER TO THIRD PARTY CUSTOMERS AS PER THEIR REQUIMENT
Course Syllabus
Topic : 1 Third Party Dossier Preparation
We are engaged in offering a qualitative Dossier Preparation Service to our valuable clients. We design and implement drug development writing projects specifically tailored to your organization and or products. We use a blend of proven operational methodologies, processes, Standard operating procedures (SOP''s), technology, infrastructure, tools, templates and the ''right'' kind of human intellect to deliver our projects consistently on time and agreed upon quality guidelines
Sadhanainfotech offers the following services in this area:
- Regulatory filings of Generics IND/NDA/ANDA/BLA/AIDS etc. to US, Europe, Canada and Row market
- Dossier Preparations: Dossier preparation and compilation as per Common technical dossier (CTD/eCTD) format/ Asian Common Technical Dossier (ACTD) Guidelines / South Africa Guidelines/ Brazil ANVISA Guidelines/ Commonwealth of Independent States (CIS) Guidelines/ South East / West Europe Guidelines
- Critical Review of Dossier and Preparation of GAP Analysis Report
- Re-formatting old Dossier/DMF, NTA to CTD/eCTD format
- Preparation of DMF/ASMF/ADMF/ CEP or (CoS): Drug Master File (DMF) compilation for open and closed parts
- eCTD preparation for EU Submission
- Technical Support in CMC-Writing, SOP Writing, Protocol Writing, Expert report (QOS) preparation
- Technical writing of Specifications, Test Procedures, Method/ Process Validation Protocols/Reports, BMR/BPR, Manufacturing Formula, and Process
- Preparation of Summary of Product (SPC), Pack Insert, Product rationale
- Dossier renewals
- Postapproval changes/ variations