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