Case Study for 505B2 Application
Regulatory Writing Services

Project Details:

  • Client: Global Pharma Company
  • Submission Country: US
  • Product Type: Antimicrobials, Muscle Relaxant, Anticonvulsants
  • Type of Submission: 505B2
  • Number of products in scope: 4
  • Request: Preparation of clinical, nonclinical overviews and Clinical and Nonclinical Summaries along with updates to USPI in compliance with PLR and PLLR requirements

Challenges:

  • Unavailability of Source documents in timely manner
  • Huge literature data along with the studies conducted by Sponsor

Delivery Approach and Value Addition:

  • Consolidation of the huge data from multiple studies and Literature
  • Experienced Authors for developing the overviews and summaries
  • Providing Optimum rationale for 505B2 (a key data for qualifying the submission for 505B2)
  • Delivering Ready to submit documents along with reference pack
  • Delivering Labeling requirements
  • PM support for planning, execution, review and finalization phases