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 Compliance | Clinical/Performance Evaluation Report Consulting & Writing | Post Market Surveillance | Medical Device Packaging & Labeling | Pharma Regulatory Compliance | Safety and Pharmacovigilance | Medical and Scientific Writing | TEDREG - A Global Regulatory Intelligence Platform

EU MDR & EU IVDR Compliance

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 and 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.

Medical and Scientific Writing

Tata Elxsi provides a wide range of medical and scientific writing service offerings to pharmaceutical, and biotech companies across the globe. We develop customized and marketable content for different communication channels to clearly and effectively communicate medical information to diverse stakeholders.

 

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+ Product Systems
Case Study

EU MDR Gap Assessment & Remediation of 330+ Product Systems

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

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

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

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 Study

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

Reduction in turnaround time by 25% for PMS documentation
Case Study

Reduction in turnaround time by 25% for PMS documentation

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

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

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

Remediating sterile and non-sterile packaging for medical devices

Reduced 70% manual efforts and 50% operational cost for pharmacovigilance
Case Study

Reduced 70% manual efforts and 50% operational cost for pharmacovigilance

50% cost reduction with blister packaging design
Case Study

50% cost reduction with blister packaging design

Clinical labeling documents as per regional guidelines
Case Study

Clinical labeling documents as per regional guidelines

Published 800+ pharma regulatory submissions for 70+ minor and major variations
Case Study

Published 800+ pharma regulatory submissions for 70+ minor and major variations

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

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 Study

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

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

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

Harnessing Technology for Intelligent Pharma Compliance Management
Blog

Harnessing Technology for Intelligent Pharma Compliance Management

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

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

EU MDR transition for packaging & labeling function
Case Study

EU MDR transition for packaging & labeling function

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

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
Technical 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 Whitepaper

MDR/IVDR Program Management – Agile Way

The New Plain Language Labeling (PLL) Regulations by Health Canada
Blog

The New Plain Language Labeling (PLL) Regulations by Health Canada

Pharmacovigilance Compliance - Changing Regulatory Landscape during Pandemic
Technical Whitepaper

Pharmacovigilance Compliance - Changing Regulatory Landscape during Pandemic

5 Emerging Markets for Medical Device Manufacturers
Business Whitepaper

5 Emerging Markets for Medical Device Manufacturers

BREXIT – Pharma Implications & Adopting the Change
Business Whitepaper

BREXIT – Pharma Implications & Adopting the Change

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