Compendia / Pharmacopeia monitoring services

Case Studies

This fortune 20 pharmaceutical company was trying to launch a product that was to be sold in global markets. This product needed to be compliant with pharmacopeia requirements.

Our assignment

GVW was to become the primary contact for all pharmacopeia needs for this pharmaceutical company. We were responsible for proactive assessments. One of the challenges in this assignment was the deletion of the Heavy Metals General chapter

Results

  • Global Value Web performed assessments on around 200+ API, DP and Raw materials.
  • We created impact assessments in a quick timeframe (within 3 months’ time).
  • Changes according to the assessments were implemented in 6 months’ time.
  • GVW supported the staff on monograph drafting/submissions as well as responses to proposals (5+).
  • Regular Monitoring and quality analyses were implemented.
  • Regulatory compliance was achieved in a relatively short timeframe.

“We have worked with GVW for over 9 years now. GVW has been part of specifications consolidation project and then moved in to take on the more transactional work related to our Compendial Vigilance and Compliance Activities. The CVC activities are still ongoing today with GVW. As our CVC program grew in scope to include the Indian, Chinese and Russian Pharmacopoeia, their work has grown as well. At each step of the way, our partner GVW would help to highlight gaps they saw in our process and way to better automate data collection and monthly metric reports that are required. It is great to have people who understand and recommend improvements to our existing processes. “

– Senior Scientist, Big Pharma Client.

Cost Savings & ROI

Quick Turn Around Time

Best Price to Performance Ratio

Continuous Engagement Model

Abarna Santhanakrishnan

Network of Excellence Leader – Lab Enabling Services

Mail : sales@global-value-web.com |

Abarna Santhanakrishnan

Network of Excellence Leader – Lab Enabling Services

Mail : sales@global-value-web.com |

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.

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