One of the therapeutic products is currently being manufactured at a manufacturing site in France.
There is a business requirement and so to ensure continuous supply, the company is planning to include its manufacturing site in Ireland as an alternative site.
So the requirement is an addition to the new site. This Product is a Non-Sterile product and there are no changes in the manufacturing process.
In total there are around 35 countries that are affected.
EU (MRP 27 countries), Argentina, Chile, Indonesia, Qatar, Russia, Singapore, Thailand and Tunisia
Given the scenario when regulatory personnel does the assessment they require information for the following few questions.
What is currently registered in each country and how those details compare with the change that is planned,
What kind of change would this be and the required documents
Whether any related or ongoing changes have been approved by a particular health authority where the product is registered.
Current Regulatory Information Framework would only provide information dump, regulatory personnel has to go through all the information sets. Only then regulatory professional would be able to take a decision. A decision can vary from individual to individual as the interpretation skills are different for different individuals.
How did VISTAAR help?
VISTAAR provides strategic information once the query is raised and would gather relevant information. Further which analytics would capture critical aspects that would help Regulatory Professionals to perform impact analysis on the above-said change in the respective regions or countries?
RA Professionals take quick decisions in implementing the change process. VISTAAR provides information on the required documents for each country, identifies all the critical parameters that the team needs to look, and finally shares information on cost implications for implementing the said change.
