As a result of repeat business, IMPACT (now part of Syner-G BioPharma Group) was contracted by a large, global pharmaceutical company to author the CSRs and accompanying submission documents to support a simultaneous US and EU submission for a combination respiratory product.
This work included authoring 9 CSRs (8 Phase 3 and 1 Phase 2b) as well as the Integrated Summaries of Efficacy and Safety (ISE and ISS), Summaries of Clinical Efficacy and Safety (Modules 2.7.3 and 2.7.4), Summaries of Biopharmaceutic Studies and Clinical Pharmacology (Modules 2.7.1 and 2.7.2), and the Clinical Overview (Module 2.5).
Initially, the project was managed by the client, but due to resource constraints, project management responsibilities for the NDA and CSRs were transferred to IMPACT’s internal project manager early during the submission process. Over the course of 12 months, IMPACT’s Project Manager worked closely with the client and IMPACT staff to ensure consistency of messaging across the CSRs and submission documents.
Nine IMPACT employees were involved with authoring, quality control, and document management of this submission. All documents produced were of the highest quality and in submission-ready format, and both marketing applications were submitted to the US and EU regulatory agencies according to the client’s timelines.
Meanwhile, during regulatory review of the marketing applications, IMPACT authored 3 Phase 3b CSRs for head-to-head comparator studies in support of product launch. The combination product was approved in both the US and the EU. Upon the successful conclusion of these submissions, IMPACT has received additional submission work from this client and has recently been selected as a preferred provider for this client.
This project epitomized IMPACT’s model of becoming an extension of a client’s project team. All team members worked closely together towards the mutual goal of application submission and product approval. This success would not have been possible without the focused and knowledgeable guidance of the client’s Project Leader and IMPACT’s Project Manager, who worked hand-in-hand to get this product to market. Our excellent relationship with this client continues to this day.
Unfortunately, our contact was unable to provide a testimonial. We’ve decided to let the repeat business from this client and our preferred provider status speak for itself.