Regulatory Affairs Technology & Data Solutions

• Full implementation, configuration, and customization of regulatory affairs technology and data solutions, including RIMS, EDMS, and eSub platforms.

• Complete vendor neutrality, including during platform assessments and recommendations.

• Integration of regulatory systems, including integrations with clinical, safety, laboratory, and manufacturing systems.

• Validation and testing of regulatory technology and data systems following risk-based CSV (Computer System Validation) and CSA (Computer Software Assurance) principles.

• RIMS implementation, configuration, and validation.

• Ongoing RIMS optimization as well as platform upgrades.

• Integration with EDMS, eSub, and connected systems such as clinical, safety, and laboratory.

• Full migration support to transition from legacy, manual, and often fragmented registration tracking.

Learn more about our RIMS solutions.

• Readiness assessment and gap analysis based on ISO IDMP requirements.

• Structured product data modeling and mapping. 

• Alignment and integration with regulatory data services such as the EMA's SPOR and PMS, plus readiness for shifts toward IDMP in other jurisdictions, including by the FDA in the US.

• Establishing compliance processes that are operational day-to-day rather than one-off events. 

Learn more about our IDMP solutions.

• Design and implementation of FHIR-based data exchange. 

• Structured content authoring that includes, where applicable, support for ePI. 

• Interoperability between regulatory systems and connected platforms such as clinical and safety systems. 

Learn more about our FHIR solutions.

• eCTD 4.0 readiness assessment and transition planning.

• Submission publishing optimization, including eliminating unnecessary manual rework when compiling submissions.

• Validation support following CSV and CSA risk-based principles.

• Alignment and integration with health authority submission gateways, including PMS (EMA) and ESG (FDA).

• Developing and implementing data ownership models and stewardship frameworks.

• Actioning data quality and cleanup to establish a strong governance baseline.

• Establishing master data management processes across regulatory systems.

• Ensuring governance processes can scale and adapt as data volumes increase, data complexity matures, and data requirements change.

• Assessing current processes and adapting them in full alignment with operational requirements and team capabilities.

• Removing unnecessary manual and repetitive work through fully and semi-automated processes.

• Change management support to harness the real-world knowledge of team members and ensure buy-in to updated processes and workflows.

• An emphasis on establishing continuous improvement principles and frameworks.

NNIT helps pharmaceutical and life sciences organizations implement, connect, and govern the technology systems and data underpinning their Regulatory Affairs function. This includes Regulatory Information Management Systems (RIMS), Electronic Document Management Systems (EDMS), and submission systems (eSub). NNIT implements, configures, and integrates these systems in line with standards such as IDMP, eCTD, and FHIR. 

NNIT is a technology and data partner, not a regulatory strategy consultancy. Therefore, the focus of its expertise and capabilities is on the platforms, integrations, and data foundations that optimize regulatory submissions and compliance processes.

Yes. NNIT supports IDMP compliance through data readiness assessments, structured product data modeling, and alignment with services such as the EMA's SPOR and PMS. NNIT also supports eCTD 4.0 through transition planning, submission system configuration, and integration with health authority gateways (e.g. PMS).

IDMP stands for Identification of Medicinal Products. It is an ISO standard that defines how medicinal products, substances, and related data are structured and identified so they can be exchanged in a consistent way between companies and health authorities. IDMP matters because regulators, led by the EU through the EMA's SPOR and PMS services, are increasingly requiring product data to be submitted in this structured, machine-readable format.

eCTD 4.0 is the next generation of the electronic Common Technical Document. This is the standard format that is used to submit regulatory dossiers to health authorities. Where the previous eCTD format is built around static, versioned document bundles, eCTD 4.0 is based on a more granular and structured data model. This updated approach allows individual elements of a submission to be tracked, reused, and managed across a product's lifecycle.

Regulatory data governance is the set of practices for managing regulatory data across an organization's systems. Key priorities include establishing clear data ownership, quality standards, and structure principles. With a defined owner, consistent structure, and traceable quality, regulatory data can be trusted and reused across RIMS, EDMS, and submission systems. As a result, regulatory data governance is the foundation that makes everything built on top of it, from submissions to IDMP compliance, faster and more reliable.

Regulatory affairs have traditionally run on documents such as PDFs and static submission files. Information like this is hard to search, reuse, or exchange, especially in a machine-readable way. Structured data changes this by breaking information down into defined, reusable fields that systems and health authorities can process directly. The shift to structured data is being driven by evolving mandates like IDMP and eCTD 4.0, both of which require structured data by design. Structured data is also essential to reduce manual rework, as data captured once in a structured way can be reused across products, markets, and submissions instead of being recreated each time.

A regulatory affairs consultancy typically provides scientific and regulatory expertise to life sciences organizations. This includes authoring submission content, advising on regulatory strategy, and liaising directly with health authorities like the FDA or EMA. A regulatory technology partner, such as NNIT, focuses instead on the systems, data, and integrations that support that work. This includes implementing and connecting platforms like RIMS, EDMS, and submission systems. It also includes ensuring the underlying data meets the structure and quality standards regulators require. The two roles are complementary rather than competing, and organizations often rely on both.

NNIT is vendor-neutral. In fact, vendor-neutrality is a core NNIT principle. As a result, NNIT works across the full range of platforms that organizations use for Regulatory Affairs. This includes RIMS platforms such as Veeva and Ennov, as well as EDMS and eSub platforms. It also includes connected systems such as SAP, LabWare, and TrackWise. Rather than favoring specific platforms, NNIT implements, configures, and integrates whichever systems fit an organization's existing landscape and requirements. As a result, all recommendations are shaped by client needs, not vendor relationships.