No longer “in the dark” when it comes to FDA inspection intelligence
Discover how a leading pharmaceutical company uses our data to always be prepared for agency inspections
Challenge
A global pharmaceutical firm manages 10 FDA regulatory inspections per year across its 100 global sites. They relied on tribal knowledge and consultants for inspection preparation with limited visibility into the latest agency trends and hot-buttons.
They were often caught off-guard by the idiosyncrasies of specific FDA inspectors.
“We need data-driven inspection intelligence. We don’t need anecdotes”
They were often caught off-guard by the idiosyncrasies of specific FDA inspectors.
“We need data-driven inspection intelligence. We don’t need anecdotes”
Solution
For strategic planning, the client leverages our Annual Observation Trend Report to discover the latest trends in 483 Observations, providing a fact-based way to focus their planning efforts on the top-cited items.
For tactical planning, the client uses our Inspector Profiles to deep-dive into the specifics of each inspector, including their CV, their categorized observations and citation history, and how they benchmark against agency averages.
For tactical planning, the client uses our Inspector Profiles to deep-dive into the specifics of each inspector, including their CV, their categorized observations and citation history, and how they benchmark against agency averages.
Impact
With access to recent and historic inspection and enforcement trends, plus knowing how inspectors behave, the teams are able to prioritize their inspection prep with precision and confidence.
See the full vendor picture
Discover how a leading distributor and medical device manufacturer uses our data to help pre-qualify vendors and to actively monitor them to stay in regulatory compliance.
Challenge
With over 10,000 suppliers, one of the largest US-based distributors and medical device manufacturers needed to improve its supplier risk-assessment and monitoring program in order to ensure FDA compliance, and improve patient safety.
“We don’t know what we don’t know.”
“Vetting is labor intensive and requires travel, which is only made more difficult with COVID.”
“We don’t know what we don’t know.”
“Vetting is labor intensive and requires travel, which is only made more difficult with COVID.”
Solution
For supplier qualification, the client leverages our Site and Organization profiles to understand and analyze the full regulatory history of its suppliers, ensuring that it adds quality into its purchasing decisions.
For ongoing monitoring, the Redica Customer Success team helped to build a monitoring portfolio of over 5,000 suppliers. Our system automatically sends notifications for any inspection or enforcement event.
For ongoing monitoring, the Redica Customer Success team helped to build a monitoring portfolio of over 5,000 suppliers. Our system automatically sends notifications for any inspection or enforcement event.
Impacct
The client experienced an immediate benefit, with a time-to-value of less than one week as an on-site audit was determined not to be necessary due to Redica’s data.
The client now has demonstrable compliance with supplier evaluation and monitoring needs.
The client now has demonstrable compliance with supplier evaluation and monitoring needs.
“Big pharma” capability, at the push of a button
Discover how a recently approved for market therapeutic drug company leveraged Redica’s External Monitoring as a one-stop-shop to get ahead of the Business Development team and to stay prepared
Challenge
With one drug in the market and a robust pipeline of candidates, the Business Development and Regulatory Affairs teams were hungry to grow revenues by submitting in more than six new markets, including the UK, Australia, Canada, China, and Japan.
The small quality team of 3 needed to ensure that it could understand and be in compliance with regulations from these new markets.
“We needed to get in front of the wave”
The small quality team of 3 needed to ensure that it could understand and be in compliance with regulations from these new markets.
“We needed to get in front of the wave”
Solution
The team utilizes our External Monitoring module, a one stop shop regulatory surveillance solution for GLP, GCP, GMP for IMP, GDP, and GMP monitoring across Human Drugs, Biologics, Medical Devices, Animal Health & IVD
Solution includes a simple dashboard that is tailored to individual needs so they only see pertinent and valuable information – no more sifting through the weeds and newsletters!
Solution includes a simple dashboard that is tailored to individual needs so they only see pertinent and valuable information – no more sifting through the weeds and newsletters!
Impact
In less than 5 minutes, the team was set up and accessing our comprehensive market coverage to help them understand regulatory requirements in new markets, new guidance and new regulations.
Team members now spend less than one hour per week to scan and triage all applicable regulatory change related to their product lines, and the time to impact was almost immediate.
“We get turn key big pharma tools and capabilities with minimal effort”
Team members now spend less than one hour per week to scan and triage all applicable regulatory change related to their product lines, and the time to impact was almost immediate.
“We get turn key big pharma tools and capabilities with minimal effort”
Out-of-the-box Digital Transformation
Discover how a global pharma company leveraged Redica to streamline their global regulatory intelligence workflows
Challenge
Quality Leadership was given the mandate to get their arms around more than 150 countries’ regulation landscape, while creating a strong process with automated and integrated tools to power the team.
Their legacy process was based on scattered and limited information, and non-automated Sharepoint technology solution that only 10% of the team was using.
Their legacy process was based on scattered and limited information, and non-automated Sharepoint technology solution that only 10% of the team was using.
Solution
One-stop-shop for all monitoring needs with the Redica External Monitoring Module – covers more than 10,000 sources across all GxPs plus RA-x and HSE, for the Human Drugs, Biologics, and Medical Devices & IVD Industries.
End-to-End automated and integrated workflows from signal monitoring all the way through reporting that engaged 100% of the global team.
End-to-End automated and integrated workflows from signal monitoring all the way through reporting that engaged 100% of the global team.
Impact
Best-in-class external monitoring process and tools at a fraction of the time and cost for internal development.
The team is engaged with information and metrics to increase collaboration and communicate performance.
The team is engaged with information and metrics to increase collaboration and communicate performance.
