End-to-end functionality helps cut
skyrocketing costs of compliance & removes workflow
inefficiencies
- The cloud-based platform demonstrates 50%+ efficiency gains
across Regulatory Operations by bringing together data, content,
and processes in a single ecosystem.
- Platform is interoperable with LifeSphere Safety
and Quality systems.
- Organizations have the option to embed LifeSphere NavaX,
ArisGlobal's next-gen cognitive computing engine, leveraging GenAI
and LLMs to support content ingestion, generation, and enhanced
insights.
BOSTON, July 11, 2024 /PRNewswire/ -- ArisGlobal, an
innovative technology company at the forefront of life
sciences and creator of LifeSphere®, today announced the
launch of its new LifeSphere® Regulatory platform, a unified
platform for end-to-end regulatory affairs management. The platform
simplifies and reinvents the regulatory workflow processes,
allowing organizations to improve visibility and data quality.
The new LifeSphere Regulatory Platform ecosystem of products
includes:
- Regulatory Information Management (RIM) - Increases data
quality, global oversight, and control with robust capabilities for
product information management, regulatory planning, tracking, and
data management.
- Products Compliance - Manages medicinal product data
submissions through submission, post-submission, and post-approval
according to the IDMP requirements and operating model.
- Documents - Establishes a single content repository for
seamless document and content management, including template
management, workflows, advanced rendering, and permissions.
- Submission Management & Publishing– Consolidates
submissions and publishing workflows in a single solution that
makes it simple to create, compile, and publish submissions in any
format.
- Labeling - Drives greater efficiency and consistency by
streamlining end-to-end labeling change management and compliance
tracking workflows.
- Regulatory Analytics - Leverages preconfigured sets of
standard dashboards and reports addressing common regulatory
tracking, reporting, and analytical needs.
Industry leaders utilizing LifeSphere Regulatory can further
power the platforms' capabilities with LifeSphere NavaX,
ArisGlobal's next-generation cognitive computing engine, to
leverage the latest GenAI and LLM features.
Today, early adopters can leverage GenAI and LLM enhancements
that are driving upwards of 50% efficiency gains, including:
- Health Authority Interactions – Accelerate the intake of
Health Authority (HA) communications and drive transparency and
consistency in HA interactions.
- Regulatory Intelligence - Monitor for regulatory updates
and build an intelligence knowledgebase to facilitate up-to-date
compliance amid changing regulations.
In 2023, ArisGlobal launched LifeSphere NavaX, which is now able
to power LifeSphere Regulatory for GenAI functionality today – and
for future roadmap use cases.
Commenting on the launch, Ann-Marie
Orange, CIO & Global Head of R&D shares, "With more
than 35 years of experience in life sciences technology, ArisGlobal
is the only technology company offering strong Safety, Regulatory,
and Quality Management solutions powered with next-generation
cognitive computing, delivering unmatched interoperability across
the R&D IT ecosystem. Over the last 18 months ArisGlobal has
made significant investment in the strategic acquisitions of
Amplexor Life Sciences and SPORIFY, along with technology R&D –
and we're not stopping."
She continues, "For current LifeSphere Regulatory customers, the
new platform will provide an enhanced experience and the ability to
deploy the latest technologies, all with simple migration. For
organizations looking to drive ROI with a new technology approach
to Regulatory Affairs, LifeSphere Regulatory is the most advanced
option and a real gamechanger for this industry. The enhanced
platform truly revolutionizes critical Regulatory processes and
drives better outcomes for life sciences organizations by readying
organizations for GenAI and LLM use cases -- we're thrilled to
relaunch LifeSphere Regulatory to the market."
ArisGlobal, with a series of new product innovations, is the
first life sciences R&D technology company to unveil targeted
solutions that make impactful use of GenAI in the industry. The
company continues to host the industry-leading GenAI Council, convening top pharmaceutical
executives, academia, and AI thought leaders to further fuel
adoption of next-generation technologies across life sciences.
To learn more about how LifeSphere Regulatory and NavaX can
transform your organization's Regulatory Affairs management, join
us for an exclusive webinar on August 7,
2024.
About ArisGlobal
ArisGlobal, an innovative life
sciences technology company and creator of LifeSphere®, is
transforming the way today's most successful life sciences
companies develop breakthroughs and bring new products to market.
Headquartered in the United
States, ArisGlobal has regional offices in Europe, India, Japan,
and China. For more updates,
follow ArisGlobal on LinkedIn or visit www.arisglobal.com.
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