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
