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