Enhancing Agility and Compliance for Life Sciences and Medical Device Industries

In the era of rapidly changing regulations and, more than ever, increased focus on pharmaceutical and healthcare services lined with scrutiny, global digitalization waves and consumer centricity, KPMG in India offers life science companies and medical device manufacturers, services catered to improving their business agility, reduced time-cost pressures and adherence to regulatory compliance. We engage with life science organizations on their process management, effectiveness, and maturity journeys. We are trusted consulting partners on managing their business transformation, compliance, regulatory, digital, and learning needs.

Our Offerings

Our process-centric offerings help mitigate and manage the current risk landscape

Integrated governance and compliance (IGC)
Consulting and Advisory (C&A)
Supplier Quality (SQ)
Digital Transformtion (DT)
Training & Learning Services (T&L)

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Key Categories

Process Setup

Pharma QMS/ISMS setup

Pharma SOP writeup

Process Effectiveness

Digital Transaformation

Data science applications

Offshore developmemt setup

Process Compliance

21 CFR Part 11, CFR 820, GxP, GDPR, HIPAA

Support for information security, Cyber risk

Regulatoy affairs management

Supplier qualification

Audits support, Control assessments

Process Performance Management

Enterprise Metrics

Supplier performance

Process Management

Enterprise Risk

RC, CAPA

GRC tool advisory

Talent and Training

Pharma training records management

New and revised regulations training

Why KPMG in India

Our services are based on the top opportunities and issues that govern the global pharma landscape. We understand the current risk landscape for life sciences and healthcare companies and therefore are well positioned to help advise and implement quality management systems (in compliance with GxP, CFR regulations, etc) and help ensure process performance metrics pave the way to measured compliance.
We help customers acquaint with emerging regulatory framework, in the pharma space through our regulatory affairs advisory service. We can help improve clinical and non-clinical processes while also working on pharmacovigilance, mergers and acquisitions, understanding cyber risk profiles and many other areas focused on consulting and advisory.
Our work also encompasses experience with supplier performance and third-party assessments, digital transformations consisting of product and portfolio management as well as learning and training on new age tools (such as data science, agile and blockchain) and on understanding changing regulatory reforms specific to life sciences and healthcare.