1.
ACCENTURE
REGULATORY
SERVICES

2.
REGULATORYPRACTICE
SERVICEOFFERINGS
Providing
Solutions for
20 years
200 skilled
Regulatory
Professionals
Experience
in major
Technologies –
Veeva RIM Partner
Active
Professional
Membership
Participation
Global
Delivery
Centers
Experience
in 90 countries
Technology/Digital
• Technology strategy road mapping
• IT Transformation / Veeva RIM
Implementation
• Regulatory automation engineering
• Labelling automation solution
• Authoring templates (StartingPoint)
Operations
• Regulatory strategy & advisory
projects
• CMC & Labelling management (incl.
authoring, change coordination)
• Major & LCM submission
management and production
− Planning & compilation
− Formatting & publishing
− Dispatch, archiving & tracking
Consulting/Strategy
• Business / Process transformation
• Program management
• Regulatory compliance assessment
and remediation programs (CMC,
Labelling)
• Change management
• Training strategy & execution
Copyright © 2019 Accenture All rights reserved. 2

3.
3
HOW
ACCENTUREIS
REDEFINING
REGULATORY
Copyright © 2019 Accenture All rights reserved.

4.
END-TO-ENDOPERATIONS
SUBMISSIONSERVICES
Lifecycle
Submission
Strategy &
Content Plan
Author
Technical
Documents
Compile &
Format Dossier
Publish &
Dispatch
Submit &
Manage HA
Interactions
Archiving &
Submission
Tracking
SUBMIT
PROJECT MANAGEMENT
CREATE TRACKPLAN
• Starting point
LCM templates
• Mod 1, labelling &
CMC authoring
• Change
assessment
• Submission
planning
Investiga-
tional
• Starting point
templates
• Mod 1, labelling &
CMC authoring
• Mod 1,
designation
requests
• Submission
planning
Investigational Application Management
Compilation, formatting & publishing, dispatch, archiving & tracking
Marketing
• Starting point
templates
• Mod 1, labelling &
CMC authoring
• Submission
planning
• Gap analysis
• Meeting support
Marketing Application Management
Compilation, formatting & publishing; dispatch, archiving & tracking
Lifecycle Submission Management
Compilation, formatting & publishing; dispatch, archiving & tracking
HA Questions
Coordination
Copyright © 2019 Accenture All rights reserved. 4

5.
Supporting our
clients by addressing
the ongoing lifecycle
management
requirements that
apply to eCTD
submissions
LIFECYCLESUBMISSIONMANAGEMENT
SUBMISSIONTIMELINES
01.
Client engages
Accenture
02.
Submission Publishing
(Document and eCTD)
03.
QC, validate submission,
receive client approval
04.
Submission dispatch
Submission
Requests
Copyright © 2019 Accenture All rights reserved. 5

6.
STARTINGPOINT
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
Functionality Features
• A tool to facilitate efficient document authoring through automation in Microsoft Word. Uses
custom styles and macros designed to assist in the authoring process and to ensure consistent
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
Accenture’s
industry-leading
submission
authoring
solution…
Copyright © 2019 Accenture All rights reserved. 6

7.
Regulatory Innovation Services
CHALLENGING ORTHODOXIES
AND SHAPING THE FUTURE
• Breakthrough design thinking workshops
• Ideation workshops
• Prototyping workshops
• MVP and prototype development
• Ecosystem & start-up partnerships
REGULATORYINNOVATION
SERVICES&AUTOMATION
Regulatory Automation
TRANSFORMING REGULATORY
THROUGH AUTOMATION
• Robotics capability assessment
• Process automation assessment
• Robotics operating model design
• Online labelling
• Patient information leaflets
Copyright © 2019 Accenture All rights reserved. 7

8.
04. Assisted Labeling Authoring &Tracking
In an automated world, AI tools can take the complexity out of
mapping global to local terms and provide end-to-end
traceability.
03. Health Authority Correspondence Processing
In an automated world, AI tools can digitize content and
automatically enter information in systems for stakeholders to
act upon.
02. Regulatory Requirements & Content Plans
In an automated world, submission contents are suggested
using AI based on past activity.
01. Creating RIM Submission Events
In an automated world, this can be done simply with Robotic
Process Automation.
INTELLIGENTAUTOMATION
REGULATORYUSECASES
RPA <10% of the
manual task duration
0.5 FTE resource
saving per 10,000
submissions
Increased compliance
and data accuracy
Reduced time and
effort with submission
preparation
Increased consistency
of fillings
Improved right first
time filing accuracy
and fewer HA
questions
Same day entry of
submission approvals
and HA question tasks
$500,000 headcount
saving per 10,000
letters
Increased compliance
and regained system
confidence
Reduced effort with
reviews and hand offs
to multiple affiliates
Increased speed in
getting updated
information to
patients
Improved compliance
with a single source of
registered information
Copyright © 2019 Accenture All rights reserved. 8

9.
LABELLINGCOMPLIANCEPROJECTS
THEBASICS
Non-compliance is not an option
• The label (prescribing
information/SmPC, patient leaflet and
packaging) incorporates all that is
important about the product and is
the point of reference for the
patient/HCP
• Mistakes in product labelling can lead
to disastrous consequences –
including product recalls
• Confirming labelling compliance is a
multidisciplinary process involving
multiple stakeholders
Project approach to confirm
compliance
Accenture’s three phased
approach:
LABELING
COMPLIANCE
Global
Regulatory
Local
Affiliate
MedicalManufact-
uring
Pharmaco-
vigilance
01.
Data Collection
02.
Gap Analysis &
Impact Assessment
03.
Remediation &
Maintenance
Copyright © 2019 Accenture All rights reserved. 9

10.
Learnmore:
Accenture.com/Regulatory
Copyright © 2019 Accenture All rights reserved. 10