ACCENTURE

REGULATORY
SERVICES
REGULATORY PRACTICE
SERVICE OFFERINGS
Operations Technology/Digital Consulting/Strategy
• Regulatory strategy & advisory • Technology strategy road mapping • Business / Process transformation
projects • IT Transformation / Veeva RIM • Program management
• CMC & Labelling management (incl. Implementation • Regulatory compliance assessment
authoring, change coordination) • Regulatory automation engineering and remediation programs (CMC,
• Major & LCM submission • Labelling automation solution Labelling)
management and production • Authoring templates (StartingPoint) • Change management
− Planning & compilation • Training strategy & execution
− Formatting & publishing
− Dispatch, archiving & tracking

Providing 200 skilled Experience Active Global Experience

Solutions for Regulatory in major Professional Delivery in 90 countries
20 years Professionals Technologies – Membership Centers
Veeva RIM Partner Participation
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HOW
ACCENTURE IS
REDEFINING
REGULATORY

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END-TO-END OPERATIONS
SUBMISSION SERVICES
Submission Author Compile & Publish & Submit & Archiving &
Strategy & Technical Format Dossier Dispatch Manage HA Submission
Content Plan Documents Interactions Tracking

PLAN CREATE SUBMIT TRACK

PROJECT MANAGEMENT

• Mod 1,
Investiga-

designation • Starting point

tional

templates Investigational Application Management

requests • Mod 1, labelling &
• Submission Compilation, formatting & publishing, dispatch, archiving & tracking
planning CMC authoring
Marketing

• Submission • Starting point

planning templates Marketing Application Management
• Gap analysis • Mod 1, labelling & Compilation, formatting & publishing; dispatch, archiving & tracking
• Meeting support CMC authoring

Lifecycle Submission Management

Lifecycle

• Change • Starting point

assessment LCM templates Compilation, formatting & publishing; dispatch, archiving & tracking
• Submission • Mod 1, labelling & HA Questions
planning CMC authoring Coordination

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LIFECYCLE SUBMISSION MANAGEMENT
SUBMISSION TIMELINES

01.
Client engages
Accenture
Supporting our
clients by addressing 02.
the ongoing lifecycle Submission
Submission Publishing
(Document and eCTD)
management Requests
requirements that
apply to eCTD 03.
submissions QC, validate submission,
receive client approval

04.
Submission dispatch

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STARTING POINT
OVERVIEW

Content Features
Over 450 CTD content templates, each relating to a particular CTD section
• Preset heading styles with appropriate CTD numbering – “boilerplate” text
• Instructional text – from ICH & regional Guidelines
• Sample text from our Regulatory Affairs group based on our 15+ year history as a
regulatory operators
Accenture’s
industry-leading
submission Functionality Features
• A tool to facilitate efficient document authoring through automation in Microsoft Word. Uses
authoring custom styles and macros designed to assist in the authoring process and to ensure consistent
solution… use of styles and standards
• Custom toolbar integrated into the MS Word ribbon as an independent tab
to make commonly-used MS Word functions more accessible
• Offers predefined heading styles, fonts, margins and table formats
to ensure a consistent look and feel across all submission documents
• Advanced authoring tools such as
document validation, PLR, Replace Styles

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REGULATORY INNOVATION
SERVICES & AUTOMATION

Regulatory Innovation Services Regulatory Automation

CHALLENGING ORTHODOXIES
AND SHAPING THE FUTURE
• Breakthrough design thinking workshops
• Ideation workshops
• Prototyping workshops
• MVP and prototype development
• Ecosystem & start-up partnerships
TRANSFORMING REGULATORY
THROUGH AUTOMATION
• Robotics capability assessment
• Process automation assessment
• Robotics operating model design
• Online labelling
• Patient information leaflets

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INTELLIGENT AUTOMATION
REGULATORY USE CASES
01. Creating RIM Submission Events 02. Regulatory Requirements & Content Plans
In an automated world, this can be done simply with Robotic In an automated world, submission contents are suggested
Process Automation. using AI based on past activity.

RPA <10% of the 0.5 FTE resource Increased compliance Reduced time and Increased consistency Improved right first
manual task duration saving per 10,000 and data accuracy effort with submission of fillings time filing accuracy
submissions preparation and fewer HA
questions

03. Health Authority Correspondence Processing 04. Assisted Labeling Authoring &Tracking
In an automated world, AI tools can digitize content and In an automated world, AI tools can take the complexity out of
automatically enter information in systems for stakeholders to mapping global to local terms and provide end-to-end
act upon. traceability.

Same day entry of $500,000 headcount Increased compliance Reduced effort with Increased speed in Improved compliance
submission approvals saving per 10,000 and regained system reviews and hand offs getting updated with a single source of
and HA question tasks letters confidence to multiple affiliates information to registered information
patients

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LABELLING COMPLIANCE PROJECTS
THE BASICS
Non-compliance is not an option Project approach to confirm
• The label (prescribing compliance
information/SmPC, patient leaflet and Accenture’s three phased
packaging) incorporates all that is approach:
important about the product and is Global
Regulatory
the point of reference for the
patient/HCP 01.
• Mistakes in product labelling can lead Data Collection
to disastrous consequences –
Pharmaco- Local
including product recalls vigilance Affiliate
• Confirming labelling compliance is a
multidisciplinary process involving 02.
LABELING Gap Analysis &
multiple stakeholders
COMPLIANCE Impact Assessment

Manufact- Medical
03.
uring Remediation &
Maintenance

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 Learn more:
Accenture.com/Regulatory

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