Regulatory & Digital Excellence for Life Sciences
Helping pharma and life sciences leaders build compliant, scalable, audit-ready digital ecosystems. From product design to operational excellence—compliance that accelerates, not slows, your business.
The Challenge Life Sciences Leaders Face
Regulatory complexity shouldn't slow down innovation. I help organizations embed compliance into their digital DNA—from product design to operational delivery.
The Problem
Enterprise software isn't built GxP-ready. Retrofitting compliance is expensive, slow, and creates audit risk.
My Approach
I embed compliance-by-design into products, build scalable CoEs, and create frameworks that accelerate time-to-value.
The Outcome
Faster product launches, 40-70% faster validation cycles, audit readiness, and customer trust through regulatory excellence.
Success Stories
Real challenges, strategic solutions, measurable impact.
Embedded GxP Compliance into Global Manufacturing Platform
SAP Digital Manufacturing
Challenge
SAP's Digital Manufacturing product needed GxP-ready features to compete in pharmaceutical manufacturing. Customers required audit trails, electronic batch records, and data integrity controls built into the core architecture—not bolted on afterward.
Approach
As Head of GxP Quality Management Center, partnered with engineering teams to conceptualize GxP functional designs. Created compliance accelerators, validation templates, and training programs for sales, QA, and development teams. Established the GxP roadmap and supported enterprise pre-sales engagements globally.
Impact
Built Scalable Compliance Operations for Global Pharma Client
Compliance Center of Excellence
Challenge
A global pharmaceutical company needed to establish L1/L2 compliance support across manufacturing, pharmacovigilance, laboratory, and quality systems. Existing validation processes were fragmented, slow, and inconsistent across regions.
Approach
Designed and launched a Compliance Center of Excellence with standardized operating models, delivery frameworks, and pricing structures. Created repeatable accelerators for validation, data integrity assessments, and quality governance. Trained client teams and managed end-to-end program delivery across multiple global sites.
Impact
Enabled SAP S/4HANA Rollout with Compliance Confidence
Global Pharmaceutical Enterprise
Challenge
A major pharma organization was migrating to SAP S/4HANA but lacked clarity on how to validate the new system while maintaining GxP compliance. The multi-vendor program involved quality, finance, supply chain, and manufacturing modules across 15+ global sites.
Approach
Designed a comprehensive validation strategy covering SDLC, change control, data migration, and cutover. Managed multi-vendor coordination, risk assessments, and test execution. Provided senior advisory support to program leadership on compliance risk and regulatory alignment throughout the transformation.
Impact
Built Compliance-Ready ITSM Models for Regulated IT Operations
Global Life Sciences Client
Challenge
Client needed to establish IT Service Management (ITSM) processes aligned with GxP requirements for incident, change, and problem management across global IT operations supporting regulated systems.
Approach
Developed a structured ITSM services framework aligned with ITIL best practices and GxP compliance. Created SOPs for service desk operations, incident management, change control, and compliance-oriented IT governance. Trained IT teams on regulatory expectations and quality processes.
Impact
Data Integrity Remediation & Governance for MES Deployment
Pharmaceutical Manufacturing
Challenge
Manufacturing Execution System (MES) deployment revealed significant data integrity gaps including inadequate audit trails, inconsistent data-flow logic, and ALCOA+ compliance issues ahead of regulatory inspection.
Approach
Conducted comprehensive data integrity assessment across MES workflows. Created remediation roadmap addressing audit trail configuration, master data governance, electronic batch record controls, and user access management. Established ongoing DI monitoring and governance framework.
Impact
Enterprise-Wide Training & Capability Development Programs
Global Pharmaceutical & Software Organizations
Challenge
Organizations needed to upskill diverse teams—engineering, sales, QA, operations—on GxP compliance, regulatory expectations, and validation methodologies to support digital transformation and product readiness.
Approach
Designed and delivered comprehensive training programs covering regulatory landscape, CSV methodologies, data integrity principles, and product compliance strategies. Created role-specific content for sales enablement, development teams, and compliance professionals. Established train-the-trainer models for sustainable capability building.
Impact
Strategic Services
From product strategy to operational delivery—compliance services that drive business value.
GxP Compliance & Regulatory Consulting
Strategic guidance on regulatory strategy, compliance frameworks, and quality governance for pharmaceutical, biotech, and med-tech operations.
- FDA 21 CFR Part 11 and EU Annex 11 compliance
- GAMP 5 framework implementation
- Quality management system design
- Regulatory audit support and inspection readiness
Digital Manufacturing & IT Transformation
Guide complex digital initiatives including cloud migrations, ERP modernization, and smart manufacturing while maintaining GxP compliance throughout.
- SAP S/4HANA and SAP DM implementation
- MES, LIMS, and ELN deployment
- Digital transformation strategy and roadmapping
- Process modernization and efficiency optimization
Computer System Validation & Data Integrity
End-to-end validation services for enterprise systems with focus on ALCOA+ principles, risk-based approaches, and sustainable compliance.
- CSV strategy, planning, and execution
- Data integrity assessments and remediation
- Validation lifecycle management
- SDLC and change control frameworks
Product Compliance & Quality Governance
Partner with software vendors to embed GxP features into product architecture and create compliance-by-design solutions for life sciences customers.
- GxP feature design: audit trails, e-records, master data
- Product roadmap and regulatory alignment
- Validation accelerators and customer enablement
- Sales enablement and pre-sales support
Audit Readiness & Inspection Support
Prepare organizations for regulatory inspections through mock audits, gap assessments, and remediation strategies that ensure compliance confidence.
- Pre-inspection readiness assessments
- Mock audit and gap identification
- CAPA management and remediation
- Regulatory inspection support
Training & Capability Building
Develop organizational capability through comprehensive training programs covering GxP compliance, validation methodologies, and regulatory expectations.
- GxP and regulatory compliance training
- CSV and data integrity workshops
- Sales enablement for compliance offerings
- Train-the-trainer programs
19+ Years Building Compliance Excellence
My career began in pharmaceutical manufacturing, where I learned the fundamentals of quality, validation, and regulatory compliance from the ground up. Over nearly two decades, I've evolved from hands-on validation work to strategic leadership roles—building compliance functions, influencing product design at global software companies, and advising C-level executives on digital transformation and regulatory strategy.
I've had the privilege of working across the full spectrum of life sciences operations: pharmaceutical manufacturing, medical device companies, SaaS platforms, and global consulting firms. This unique combination of industry-side experience and product-side innovation gives me a 360-degree perspective on compliance challenges—and how to solve them in ways that drive business value, not just check regulatory boxes.
At SAP, I shaped the GxP roadmap for Digital Manufacturing, working directly with engineering teams to embed regulatory intelligence into the product architecture. At PharmaX Solutions and leading consulting firms, I've designed and scaled Compliance Centers of Excellence, built repeatable validation accelerators, and established governance models that serve Fortune 500 pharmaceutical and biotech clients globally.
Today, I partner with pharmaceutical leaders, software vendors, and life sciences innovators to navigate the intersection of compliance, technology, and business strategy. Whether it's embedding GxP-by-design into products, leading enterprise-scale digital transformation, or establishing scalable compliance operations—I bring strategic vision, execution excellence, and a proven track record of delivering measurable outcomes.
Core Expertise Areas
Proven Track Record
"Priyanka's expertise in GxP compliance transformed how we approach product development. Her guidance on embedding compliance-by-design saved us months of validation time and strengthened our market position."
"Working with Priyanka elevated our SAP product's compliance capabilities. Her strategic vision and hands-on execution made us a trusted partner for life sciences customers worldwide."
"The Compliance CoE Priyanka designed for our organization became the foundation of our global quality operations. Her frameworks are still driving efficiency three years later."
Industry Recognition
Guest faculty at Sharda University | White paper author | Speaker at industry forums including cPHI and UCB CSV Workshop | 18.5K+ LinkedIn professional network
Ready to Embed Compliance into Your Digital Strategy?
Whether you're building GxP-ready products, scaling compliance operations, or navigating digital transformation—let's discuss how I can help.
Free Resource
Download the GxP-Ready Digital Transformation Playbook — A practical guide for life sciences leaders navigating compliance in digital initiatives.