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Case Study for Clinical and Nonclinical Overviews
Regulatory Writing Services
Project Details:
Client: Global Pharma Company
Submission Country: EU
Product Type: Generic products
Type of Submission: CP or DCP
Number of products in scope: 20
Request: Preparation of the clinical and nonclinical overview and the applicable summaries for the generic products as per the ICH CTD templates
Challenges:
Stringent timelines
Products with Multiple Indications
Review approach
Huge data for some of products
Delivery Approach and Value Addition:
Extensive literature search
Consolidation of the huge data from literature and presenting it in a concise way
Experienced Authors for developing the overviews and summaries
Authoring overviews and summaries as per the region and product applicability
Delivering Ready to submit documents along with reference pack
Modules 1.4.2 and 1.4.3 for submission
PM support for planning, execution, review and finalization phases