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REGULATORY AFFAIRS

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. Our services and solutions are designed to:

  • 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

 

With NNIT as your partner, your Regulatory Affairs function becomes not just compliant – but a driver of speed, quality, and competitive advantage.

Where We Focus Our Expertise

Our Regulatory Affairs Offerings

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.

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.

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.

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. 

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.

Discover more about our OCM approach 

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

How we work

Real-World Impact: Client Case Examples

See how we’ve helped Regulatory Affairs teams succeed.

Customer: Top 20 Global Life Sciences Company
NNIT led the end-to-end implementation of Veeva Submissions, Submissions Archive, and Registrations modules. 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 modules, delivered on time and aligned with the client’s strategic roadmap.

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 Alignment

Our Team:
Improved data readiness and sustained IDMP compliance – laying the foundation for efficient submissions in the future.

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 Governance

Our Team:
Accelerated readiness for structured submissions and a clear path to long-term efficiency through modern data models.

Ready to transform your Regulatory Affairs function?

Connect with one of our RA specialists to explore how structured data, system optimization, and AI-driven solutions can accelerate your success.

Get in touch with NIDD@nnit.com or fill the contact card below.

Our experts are ready to help

Contact us, and we will find a solution that suits your needs

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