Enabling Change Management Service
A pharmaceutical company with more than 20 manufacturing sites, received a US-FDA 483 to one site. A remediation plan was formed, but implementing this plan, as scheduled, proved to be a challenge.
GVW was asked to prepare prepared gap assessments and impact assessments, as a part of the company’s remediation team.
- Our Project Professionals created 20+ change controls.
- We managed the workflow by connecting with 50+ stakeholders and implemented the desired changes within 6 months timeframe.
- Ontime implementation resulted in timely regulatory compliance
- Stakeholder Satisfaction increased
“This is a huge accomplishment taking into account the time and follow up it took to get the CC’s in execution stage and limited time we had to do all the updates on spec and other related documents. GVW coordinated and followed up very well and quality of the delivered work was good.”
– Senior Scientist, Small Molecule Drug Product Development, Big Pharma client
Cost Savings & ROI
Quick Turn Around Time
Best Price to Performance Ratio
Continuous Engagement Model
Global Value Web is a network of data experts and technology partners that allow organizations to make the most out of their data. We offer valuable insights across the value chain that will lead to more efficient production processes and reliable quality products. We focus on a better execution today, while keeping in mind the challenges for tomorrow. With our shared knowledge and expertise, we prepare your data flow for a bright and profitable future.
Read more about GVW’s Pharma Life Cycle Data Management Service for Pharma & Life Sciences