Regulatory Intelligence: Navigate regulatory puzzle with Regulatory intelligence technology

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Regulatory IntelligenceNavigate regulatory
puzzle with Regulatory intelligence technology
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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.

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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 RD process solely and ensures
  that you have a timely approval.

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