Regulatory Affairs
Bring your RA setup into the future
Setting a New Standard for Regulatory Affairs
Regulatory Affairs (RA) organizations face growing complexity. Regulations evolve rapidly, documentation demands intensify, and expectations for structured data and system interoperability continue to rise.
To succeed, RA teams need to shift from document-driven processes to data-driven operations – enabling transparency, speed, and compliance across the product lifecycle.
NNIT partners with life sciences companies to make this shift a reality. We help RA functions streamline processes, ensure Identification of Medicinal Products (IDMP) compliance, enhance data quality, and realize the full value of systems such as Regulatory Information Management Systems (RIMS), Electronic Document Management Systems (EDMS), and other platforms – turning regulatory complexity into a competitive advantage.
What We Help You Achieve
NNIT helps Regulatory Affairs teams transform complexity into control. By strategically combining deep domain knowledge with proven technologies, we enable our clients to focus on what truly matters: achieving faster compliance and better outcomes through reliable, efficient, and future-ready regulatory operations. With NNIT as your partner, your Regulatory Affairs function becomes not just compliant – but a driver of speed, quality, and competitive advantage.
-
Enable data-driven regulatory operations
Helping you move beyond document management to structured, connected data that supports faster, smarter decisions.
-
Ensure compliance and readiness
With deep expertise in evolving requirements such as Substance, Product, Organization and Referential (SPOR) data, IDMP, electronic Common Technical Document version 4.0 (eCTD 4.0), and other global standards
-
Maximize value from your platforms
Regardless of system or platform, we help you optimize processes and technology use through a vendor-neutral approach
-
Accelerate time to market
By streamlining submissions, improving data quality, and enabling automation where it matters most
-
Strengthen collaboration
Ensuring transparency and alignment across Regulatory, Quality, Supply Chain, and external partners
Where We Focus Our Expertise
Connected Data Operations: We help you move from document-based work to connected, structured data flows – enabling automation, improving accuracy, and driving consistency across the lifecycle.
Regulatory Compliance Readiness: Our experts stay on top of evolving requirements such as IDMP, SPOR, and eCTD 4.0 – ensuring your processes are aligned, inspection-ready, and globally compliant.
System-Agnostic Process Design: We tailor solutions to your platform – whether commercial or custom – to ensure long-term business value, usability, and governance.
Time-to-Market Acceleration: From regulatory intelligence dashboards to optimized processes, we create the conditions that allow your team to submit faster – with full control and confidence.
Cross-Functional Enablement: We ensure that Regulatory doesn’t operate in a silo – by supporting stronger collaboration across functions and integrating insights from Quality, Supply Chain, and Clinical.
Our Regulatory Affairs Offerings
Today’s Regulatory Affairs function is evolving – driven by new technologies, increasing complexity, and growing data demands.
At NNIT, we help regulatory teams navigate this landscape through digital implementations, process optimization, data strategy, and change enablement.
Explore our offering areas below to see how we support faster submissions, stronger compliance, and smarter regulatory operations.
-
Regulatory Digital Implementations
NNIT helps Regulatory Affairs organizations design, implement, and optimize digital solutions that connect systems, data, and people.
We offer full end-to-end capabilities across the entire system lifecycle. Our vendor-neutral approach ensures you:
-
Define clear business requirements
-
Identify and select the right vendor based on your needs
-
Collaborate during system configuration to align technology with business objectives
-
Secure adoption through structured onboarding, training, and validation support
-
Enable ongoing optimization and innovation as regulatory and business needs evolve.
Whether implementing a new system or optimizing an existing one, we help you deliver results faster – and with greater confidence.
-
-
Process Improvement
We partner with Regulatory Affairs teams to streamline ways of working, reduce manual effort, and enable operational excellence.
Our pragmatic and collaborative approach helps you:
-
Identify inefficiencies in regulatory operations
-
Harmonize processes across geographies and product types
-
Increase efficiency, reduce manual burden, and minimize risk
-
Accelerate time to market and maintain inspection readiness
We focus on practical improvements that scale and sustain.
-
-
IDMP Advisory and Solutions
NNIT provides targeted advisory and practical solutions to help you meet IDMP requirements while creating lasting business value.
Navigating IDMP compliance doesn’t have to be complex. We support you in:
-
Building a future-ready IDMP strategy
-
Structuring and maintaining data to ensure regulatory alignment
-
Establishing robust governance for ongoing data maintenance and oversight
-
Enabling reuse of data across functions
We help transform IDMP from a compliance task into a strategic enabler.
-
-
Data & FHIR
NNIT helps Regulatory Affairs teams prepare for a future built on structured data, automation, and seamless data exchange.
Our expertise enables you to:
-
Apply Fast Healthcare Interoperability Resources (FHIR) and related data standards to regulatory processes
-
Enable seamless exchange of data across platforms
-
Build a robust architecture to support automation and analytics
-
Lay the foundation for smarter, faster submissions
We help future-proof your regulatory data landscape.
-
-
Organizational Change Management (OCM)
Accelerate adoption, boost motivation, and make change stick.
Unlock better results in your life sciences projects with NNIT’s Organizational Change Management (OCM) expertise. Our dedicated consultants help you achieve smoother transitions, boost team motivation, and deliver sustainable outcomes – ensuring change becomes a positive force in your organization.
Why choose NNIT for Regulatory Affairs?
We combine deep Regulatory Affairs domain knowledge with proven digital expertise
We focus on practical, business-driven solutions – not just technology for its own sake
We help you turn regulatory compliance challenges into opportunities for efficiency, quality, and speed
Real-World Impact: Client Case Examples
See how we’ve helped Regulatory Affairs teams succeed.
From global implementations to data-driven compliance initiatives, our Regulatory Affairs experts deliver results that last.
Explore the examples below to see how we’ve helped life sciences companies optimize systems, improve data readiness, and accelerate regulatory success – across IDMP, FHIR, Veeva RIM, and more.
-
Multi-Module Veeva RIM Implementation
Customer: Top 20 Global Life Sciences Company
NNIT led the end-to-end implementation of Veeva Submissions, Submissions Archive, and Registrations Vaults. Working seamlessly with both the client and Veeva, we supported multiple workstreams – from Phase 0 scope analysis and business process design to integration, migration, testing, validation, and business roll-out. Our structured and collaborative delivery ensured timely completion and alignment with the client’s expectations.
Key Results:
-
Three Modules implemented with coordinated timelines
-
Full business alignment and adoption at go-live
-
Zero delays despite multi-stream complexity
Capabilities Applied:
✓ Business Process Engineering
✓ Validation & Testing
✓ Project & Program Management
✓ OCM & Roll-Out
Customer Value:
Successful implementation across multiple RIM vaults, delivered on time and aligned with the client’s strategic roadmap.
-
-
IDMP Advisory & Data Remediation
Customer: Mid-Sized Pharma Company
To help the client prepare for IDMP compliance, NNIT conducted in-depth business, system, and data process reviews. We guided the redesign of practices and supported data remediation to enable accurate, structured data migration to a new submission system. Our advisory ensured current compliance while futureproofing the organization against upcoming regulatory changes.
Key Results:
-
Comprehensive assessment of data gaps and readiness
-
Successful alignment with evolving EU IDMP requirements
-
Data structured and prepared for migration and reuse
Capabilities Applied:
✓ IDMP Advisory & Requirements Gathering
✓ Data Governance
✓ Validation & System AlignmentOur Team:
Improved data readiness and sustained IDMP compliance – laying the foundation for efficient submissions in the future. -
-
IDMP & FHIR Enablement for Submission Acceleration
Customer: Top 10 Global Pharma Company
To reduce submission effort and timelines, NNIT partnered with the client to deliver deep IDMP and FHIR expertise. We led data management advisory work and developed FHIR-based Proofs of Concept to modernize how regulatory data is structured and submitted. This enabled the client to both meet IDMP standards and unlock future efficiencies.
Key Results:
-
Working FHIR Proofs of Concept built for structured submissions
-
Reduced manual effort and redundancy in regulatory processes
-
Roadmap created for future automation of product data
Capabilities Applied:
✓ IDMP & FHIR Advisory
✓ System & Data Analysis
✓ SME-Driven Data GovernanceOur Team:
Accelerated readiness for structured submissions and a clear path to long-term efficiency through modern data models. -
Insights
Articles
Life Sciences, Regulatory Affairs, Data
Navigating the Transition from XEVMPD to PMS: Preparing for IDMP Compliance
Online Events
Life Sciences, Regulatory Affairs
A Practical Guide to IDMP Compliance
Online Events
Life Sciences, Regulatory Affairs
First Time Launch Alliance: Paving the Path to Successful Pharma Product Launches
Online Events
Life Sciences, Regulatory Affairs
Success for First-Time Drug Launches: How Early IDMP Adoption Reduces Risk & Accelerates Approval
White Papers
Life Sciences, Data, Clinical, Drug Safety, Regulatory Affairs
Ensure that your critical data is trustworthy
Online Events
Life Sciences, Regulatory Affairs
Automated Regulatory Data Extraction and Verification
Articles
Life Sciences, Regulatory Affairs
Unlocking the Potential of Regulatory Data Requires Adoption of Artificial Intelligence and Machine Learning
