To comply with time-critical labeling mandates, organizations face many procedural challenges while creating, tracking and managing various aspects of drug labeling lifecycle. In that regard, before even searching for a right labeling solution.....

1. REGULATORY LABELING AND
THE INDUSTRY CHALLENGES
A Deep-dive

2. 2REGULATORY : CONSULTING | SUBMISSIONS | AFFAIRS | SUPPORTING | INTELLIGENCE | LABELING | SOFTWARE
To comply with time-critical labeling mandates, organizations face many procedural challenges
while creating, tracking and managing various aspects of drug labeling lifecycle.
In that regard, before even searching for a right labeling solution, isn’t it required to know and
decode what exactly are those challenges?
Regulatory Labeling and the
Industry Challenges

3. 3REGULATORY : CONSULTING | SUBMISSIONS | AFFAIRS | SUPPORTING | INTELLIGENCE | LABELING | SOFTWARE
Of, course YES!!! The need of the hour is to understand the challenges from various perspectives,
such as:
Business-oriented Functional-based Technical / operational
Regulatory Labeling and the
Industry Challenges

4. 4REGULATORY : CONSULTING | SUBMISSIONS | AFFAIRS | SUPPORTING | INTELLIGENCE | LABELING | SOFTWARE
Business Continuity
Centralization &
Harmonization
Fear of non-compliance
Impact on brand image Productivity, efficiency and cost
Business-oriented Regulatory
Labeling Challenges

5. 5REGULATORY : CONSULTING | SUBMISSIONS | AFFAIRS | SUPPORTING | INTELLIGENCE | LABELING | SOFTWARE
Establishing processes
Pacing with ever-evolving guidelines and
region-specific formats
Dealing with Knowledge gaps
Functional-based Regulatory
Labeling Challenges

6. 6REGULATORY : CONSULTING | SUBMISSIONS | AFFAIRS | SUPPORTING | INTELLIGENCE | LABELING | SOFTWARE
Technical/Operational Regulatory
Labeling Challenges
Challenges in CDS creation and
deviation tracking
Multiple platform Integration
Integration of document creation within
CDS management
Track changes in CDS
Document creation, tracking and
deviation tracking
Deviation reporting and compliance
tracking

7. 7REGULATORY : CONSULTING | SUBMISSIONS | AFFAIRS | SUPPORTING | INTELLIGENCE | LABELING | SOFTWARE
With the complete spectrum of Regulatory labeling industry
challenges defined, what you think should be your next step?
Adopt a Global Labeling Xcellence Framework.

8. For any query,
we are delighted to assist you.
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