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Complete portfolio support
Complete portfolio support
Client:
Medium-sized Pharmaceutical company.
Client Challenge:
Our client adopted a new business strategy that required a thorough examination of all current operations and strategies by G&L.
This resulted in the identification of the need for urgent support of a number of key functions including CMC strategy authoring, publishing and submission.
In addition to this, G&L was also tasked with defining new operational processes, driving efficiency gains and cost savings and refocusing regulatory FTEs for more strategic activities.
G&L Solution:
G&L provided a global delivery team, working from our UK, India, and US offices to manage, author and deliver:
- Global CMC Support (35+/- marketed products)
- Post-approval variations/supplements (~450-1000/ year)
- License Renewals (all markets) (~50-100+/ year)
- Baseline dossier creation/ gap analysis (~25/ year)
- Emerging markets dossier authoring and submission preparation (50+/ year)
- Responses to Health Authority questions
- Submission planning/publishing activities for MAA's, variations, renewals, CTA's, CSR’s
Outcome:
An observable, positive trend in both quality and timeliness KPIs from the initial phase. All KPIs were either met or exceeded.
In addition to this, efficiency gains were successfully realized and engagement has moved into the cost-saving phase.
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