Regulatory Compliance

Navigate complex and evolving regulatory landscape with confidence and certainty

The global regulatory landscape has dramatically evolved over the years to ensure a high degree of device efficacy and patient safety. As healthcare companies are adhering to the regulatory framework of the operating markets and continuously exploring new growth opportunities, managing the high volume of work while containing the cost of compliance has become the key to sustainable business.

Products & Services

EU MDR/IVDR implementation, clinical/performance evaluation report consulting and writing, post market surveillance, medical device packaging & labeling, pharma regulatory compliance, safety and pharmacovigilance, pharma packaging and labeling, TEDREG-a global regulatory intelligence platform

EU MDR/IVDR Implementation

Accelerate to meet EU MDR/IVDR compliance efficiently well before the deadline without restricting programs critical for business growth. ​Tata Elxsi's outcome-based "Compliance Assurance Model" ensures EU MDR/IVDR compliance certainty while its proprietary agile-based "ScrumDR methodology" overcomes the complexities of the transition process.

Clinical/Performance Evaluation Report Consulting & Writing

Mitigate the impact of global regulatory changes on your clinical affairs function. Tata Elxsi's experience over the years, coupled with its repository of ready-to-use checklists and templates, allows it to deliver high-quality CER, SSCP, PSUR, PMCF reports, among others, across all safety classes and medical device specialties.

Post Market Surveillance

Tata Elxsi helps manufacturers minimize clinical risk exposure and detect/predict potential product failures in the field through effective complaints management program and proactive post-market oversight. Furthermore, Tata Elxsi ensures product sustenance in the market by efficiently identifying the need for preventive, corrective, or field safety action.

Medical Device Packaging & Labeling

Tata Elxsi helps manufacturers standardize and automate labeling workflow across multiple manufacturing sites, thus saving significant costs associated with the product launch, sustenance, rebranding, and recalls due to mislabeling. Tata Elxsi also supports the companies in designing & developing sterile packaging and aseptic presentation in compliance with ISO 11607-1 and ISO 11607-2.

Pharma Regulatory Compliance

Tata Elxsi helps companies in striking a balance between complex pharma regulatory documentation requirements through its homegrown global regulatory intelligence platform and cost-effectiveness amidst the dynamic and evolving regulations through optimization across the regulatory value chain.

Safety & Pharmacovigilance

Tata Elxsi helps pharma & life sciences businesses in consolidating and standardizing internal processes and automating labor-intensive high volume tasks to streamline safety documentation for proactive action, operational efficiency, and enhanced market confidence in the brand.

Pharma Packaging & Labeling

Tata Elxsi's pharma labeling services help manufacturers centralize, streamline, and automate label development processes to maintain label accuracy and integrity across the supply chain, while its packaging services help in designing sustainable packaging to ensure patient safety, longer product shelf life, and brand authenticity.

TEDREG - A Global Regulatory Intelligence Platform

An intelligent platform built to aggregate and organize the latest regulatory updates from major regulatory bodies across the globe and provide actionable insights to the manufacturers for new market launches and product sustenance in the existing markets.

Insights & Experiences

EU MDR gap assessment & remediation of 330+ surgical product families in a span of 11 months
Case Studies

EU MDR gap assessment & remediation of 330+ surgical product families in a span of 11 months

Reduction in turnaround time by 20 – 25% for CER creation
Case Studies

Reduction in turnaround time by 20 – 25% for CER creation

Updating the CERs as per EU MDR guidelines (Class II and III)
Case Studies

Updating the CERs as per EU MDR guidelines (Class II and III)

Clearing complaints backlog of 15000+ recall products within a span of 7 months
Case Studies

Clearing complaints backlog of 15000+ recall products within a span of 7 months

Reduced turnaround time by 25% by ensuring quality deliverables for PMS documentation as per EU MDR
Case Studies

Reduced turnaround time by 25% by ensuring quality deliverables for PMS documentation as per EU MDR

Centralized label management software leading to 30 – 35% increase in efficiency
Case Studies

Centralized label management software leading to 30 – 35% increase in efficiency

Remediating sterile and non-sterile packaging for medical devices
Case Studies

Remediating sterile and non-sterile packaging for medical devices

Reduced up to 70% manual efforts and 50% operational cost through automated pharmacovigilance workflow
Case Studies

Reduced up to 70% manual efforts and 50% operational cost through automated pharmacovigilance workflow

50% cost reduction with blister packaging design
Case Studies

50% cost reduction with blister packaging design

Clinical labeling documents as per regional guidelines
Case Studies

Clinical labeling documents as per regional guidelines

Published 800+ submissions and 70+ minor and major variation submission for a leading global pharma company
Case Studies

Published 800+ submissions and 70+ minor and major variation submission for a leading global pharma company

An agile, sustainable, and scalable lifecycle management operations for the regulatory function of a US-based pharma
Case Studies

An agile, sustainable, and scalable lifecycle management operations for the regulatory function of a US-based pharma

30% increase in regulatory function productivity of a European biotechnology company
Case Studies

30% increase in regulatory function productivity of a European biotechnology company

40% improvement in compliance cost for a Japan-based pharmaceutical company
Case Studies

40% improvement in compliance cost for a Japan-based pharmaceutical company

Adverse Event Reporting: Power of AI Enabled Cognitive Case Processing and Process Automation
Whitepaper

Adverse Event Reporting: Power of AI Enabled Cognitive Case Processing and Process Automation

EU MDR transition for packaging & labeling function of a leading cardiovascular product manufacturer
Case Studies

EU MDR transition for packaging & labeling function of a leading cardiovascular product manufacturer

Decoding the New European Union In-Vitro Diagnostics (IVD) Medical Device Regulation 2017/746
Technical Whitepapers

Decoding the New European Union In-Vitro Diagnostics (IVD) Medical Device Regulation 2017/746

Unfolding the EU MDR through the Lens of a Remediation Partner
Whitepaper

Unfolding the EU MDR through the Lens of a Remediation Partner

Global Regulatory Requirements and Manufacturers Responsibilities for Medical Device Vigilance Reporting
Whitepaper

Global Regulatory Requirements and Manufacturers Responsibilities for Medical Device Vigilance Reporting

MDR/IVDR Program Management – Agile Way
Technical Whitepapers

MDR/IVDR Program Management – Agile Way

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