This document discusses regulatory compliance challenges in the life sciences industry. It notes that regulatory scrutiny has increased globally, resulting in more inspection findings and requirements for remediation. This has made quality and compliance more important and risky. Deloitte can help life sciences companies address these challenges through services such as remediation of quality issues, gap assessments, and compliance with regulations regarding areas like marketing practices and electronic records.

1. Mitigating risks arising from non-compliance
in the Life Sciences sector
Maintaining a cost-effective balance between
compliance and risk
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Introduction
Quality parameters in the Life Sciences industry are
changing1
. Quality, in this industry, is no longer just
limited to manufacturing processes and relegated to
pages of obscure metrics about process parameters.
Regulators no longer see it as just rework rates and
recalls. Quality needs to pervade the entire product
life cycle from development and clinical trials through
manufacturing, distribution, and post market
surveillance.
Regulatory scrutiny is increasing globally, resulting in
more inspection findings, more site and corporate wide
remediation requirements, and even product supply
chain interruptions, thus, making quality and compliance
more important (and riskier) than ever.
In response to this increased regulatory enforcement, the
definitions and objectives of quality and compliance have
become blurred, and in some cases merged, causing
confusion and conflict within organizations. Remediation
efforts have been focused on implementing stop-gap
measures to resolve compliance issues that may not be
efficient in running the business or effective in improving
product quality. These corrective actions, in many cases,
are not sustainable because they increase the complexity
of the process and/or the cultural change within the
organization has not matured sufficiently.
Deloitte can deliver practical solutions to clients’ quality
and compliance challenges.

2. 2
Our approach
We bring a cross-disciplinary perspective to our Life
Science industry clients to help them address complex
and competing requirements, emerging Government
and regulatory enforcement trends, and evolving leading
industry practices. Our professionals provide:
• Broad and deep global regulatory and compliance
knowledge and experience
• Efficient, effective application of regulatory risk and
control concepts
• Broad understanding of the dynamics and business
processes of Pharmaceuticals industry
• Demonstrated capabilities in diagnostic,
transformational, monitoring and investigational
segments
Areas where Deloitte can assist your organization to
resolve quality and compliance issues and improve
process efficiency and effectiveness include:
• Remediation of findings related to operational quality
problems, including US Food and Drug Administration
(FDA) benchmarks, regulators response strategy,
validation and testing, Corrective Actions and
Preventive Actions (CAPA), quality system assessment
and training.
• Remediation and gap assessment: Research and
Development (RD), manufacturing/quality and supply
chain operations
• IT quality, compliance, and operations strategy
pertaining to FDA and European Union guidelines on
electronics records and signatures in the Life Sciences
industry (popularly referred to as Part 11/Annex 11
compliance)
• Compliance with legislations like the Foreign Corrupt
Practices Act (FCPA) and the UK Bribery Act ( UKBA),
Whistle Blower compliances, investigation of sales and
marketing related frauds such as sales commission
fraud, dumping of goods and other corrupt practices
The Deloitte difference
Deloitte services in India bring together individuals from
across geographies with significant local and global Life
Sciences industry and regulatory experience. Globally,
we are recognized as a leader in end-to-end compliance
management services.
1
The industry encompasses pharmaceutical, biological,
medical device and biotechnology products.
Contact us
To discuss your business challenges and possible solutions, please contact:
Rohit Mahajan
Senior Director
Deloitte Touche Tohmatsu India Pvt. Ltd.
Tel: +91 22 6185 5180
E-mail: rmahajan@deloitte.com
Nitin Bidikar
Director
Deloitte Touche Tohmatsu India Pvt Ltd.
+91 982 080 9199
E-mail: nbidikar@deloitte.com
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