1 / 4

Regulatory Intelligence: Navigate regulatory puzzle with Regulatory intelligence technology

It is regulatory intelligence that will equip you thereby enabling every regulatory personnel to give strategic advice to others based on their regulatory needs. The utmost benefit that a pharma and medical device companies derives from regulatory intelligence is the highest standard of submission that primarily ensures that the chance of approval is higher. <br>

vistaarai
Download Presentation

Regulatory Intelligence: Navigate regulatory puzzle with Regulatory intelligence technology

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. Regulatory IntelligenceNavigate regulatory puzzle with Regulatory intelligence technology

  2. Regulatory Intelligence Regulatory Intelligence (RI) Collection and analysis of various forms of regulatory data can be considered to be regulatory intelligence. You can never consider all regulatory data to be part of the RI, only the relevant ones that are reached through filtration do fall under this category. It is regulatory intelligence that will equip you thereby enabling every regulatory personnel to give strategic advice to others based on their regulatory needs. The utmost benefit that a pharma and medical device companies derives from regulatory intelligence is the highest standard of submission that primarily ensures that the chance of approval is higher. Where is Regulatory Intelligence Applicable? It is the Regulatory Affairs team that builds this regulatory intelligence through continuous research and analysis and also by keeping a track of the regulatory changes across the world. This analyzed data is majorly used in the successful submission of applications for approval under any regulatory body. A single change or update in the registration process or guidelines of a regulatory authority might have a severe impact on the entire product approval process. So continuous vigilance is necessary and that is ensured through this updated RI. What is the Need of it? Whenever we are introduced to something new, the first thing that we search for is whether it is necessary or not. Similarly for Regulatory Intelligence, the same question arises time and again. To know that we need to know the reason that leads to failed submissions. The ever-changing regulatory guidelines lead to issues of non-compliance which is behind this huge number of recalls. The companies eventually face severe losses both monetarily as well as of resources. This could have been prevented with Regulatory intelligence as keeping track of the regulatory updates become easy.

  3. Regulatory Intelligence Your Gain You save your time and effort. Readily available regulatory intelligence from across the world. You get a clear view of the advantages and drawbacks that might surface during approval. Regular updates from the Regulatory Authorities are made available to you. You get to check your compliance level. Segregated Regulatory data for drugs, devices, and biologics. Specific data mentioning clinical, non-clinical, labelling, packaging, storage instructions, quality control, safety and efficacy, recall rules, template for submission, and such others. More specifically, your pattern of submission projects you broadly in the global market under its authorities. What VISTAAR Offers? Vistaar is a regulatory intelligence tool that comes with a database of 100+ countries Regulatory summary reports, 69k+ approvals, 960k+ regulatory documents and 110k+ product label data. This DB is the biggest and continuously updated on a daily basis as and when the regulatory authority issues any updates. Using Artificial Intelligence and Machine Learning we provide the updates faster and that too at the industry best price point for a best possible ROI. Thereby, offering you ample time to concentrate on the R&D process solely and ensures that you have a timely approval.

  4. THANK YOU

More Related