Regulatory Compliance

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biggest brands

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Our Regulatory Compliance Services

ePI (Electronic Product Information)

Manage end-to-end product labeling with intelligent tools that ensure accuracy, version control, and audit readiness across global regulatory frameworks. Our ePI solutions streamline updates and support faster, compliant submissions.

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Legacy to FHIR Conversion

Seamlessly convert legacy product and labeling formats (Word, IDMP, PDF, XML, SPL) into FHIR-compliant structures for regulatory readiness and interoperability. Enable integration with digital health systems and streamline submission workflows.

AI

Gen AI-Powered Summarization & Translation

Leverage AI to generate concise regulatory summaries and accurate multilingual translations, reducing errors and speeding up global submissions. Our Gen AI powered intelligent tools enhance efficiency and support faster approvals.

Transform Compliance into Competitive Advantage

Benefits

  • Accelerate Regulatory Approvals
  • Ensure Market-Ready Accuracy
  • Safeguard Brand & Patient Trust
  • Minimize Compliance Risk
  • Optimize Time & Cost

Why Deevita

  • Deep Standards Expertise
  • Tailored Solutions for Global Needs
  • Accelerated Time-to-Value
  • Secure, Scalable Technology
  • Innovation-Driven Approach

Our Regulatory Compliance Solutions

FHIR Conversion

Digitally transform legacy labeling formats into FHIR-compliant structures for faster approvals and seamless regulatory interoperability.

AI-Powered Summarization & Translation

Automatically generate concise, multilingual product summaries to streamline global submissions and reduce manual errors.

Regional Compliance Readiness

Ensure alignment with EMA, FDA, and other regional ePI standards using structured, standardized product information.

Regulatory Compliance Use Cases by Industry

Faster Regulatory Approvals

Life Sciences

Change
Problem

Regulatory submissions often get delayed because product information exists in multiple legacy formats (Word, PDF, XML, SPL). Manual conversions not only increase workload but also introduce errors and inconsistencies, slowing down approval timelines

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Solution

FHIR-based conversion standardizes product information into regulator-ready formats, eliminating manual work

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Impact
  • Shortened submission timelines
  • Reduced approval delays
  • Faster product launch
Multilingual Compliance at Scale

Life Sciences

Change
Problem

Manual translations of PI often cause inconsistencies, misinterpretations, and compliance risks. Regulators demand clarity and accuracy in every language version, making manual processes highly inefficient and error-prone

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Solution

AI powered translation and compliance validation deliver consistent content across multiple languages. Automated workflows reduce human error, speed up review cycles, and ensure every submission is aligned with regional requirement.

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Impact
  • Consistent global labeling
  • Reduced risk of misinterpretation
  • Improved regulator trust
Patient-Centric Information Delivery

Life Sciences

Change
Problem

Patients and healthcare providers often face difficulties accessing accurate, up-to-date product information, especially with regional variations and paper-based labeling

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Solution

Electronic Product Information (ePI) enables real-time access to structured, standardized product details on digital platforms, improving patient engagement and safety

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Impact
  • Improved patient safety through up-to-date information
  • Enhanced healthcare provider trust
  • Supports digital-first, sustainable initiatives

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Transform Outcomes with Intelligent Data. Your Data. Our Expertise. Better Health.