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Indegene
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Enterprise Medical Solutions
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What we do Enterprise Medical Solutions

Enterprise Medical Solutions

Communicate scientific information effectively, improve regulatory compliance and manage safety operations efficiently

Existing medical operations are

Suboptimal

to meet changing expectations on medical and scientific content

Unscalable

to meet growing volume of adverse events being reported

Overstretched

to comply with rapidly changing regulations across markets

What we do

Omnichannel Medical Strategy

Every life sciences company is at a different level of omnichannel medical operations maturity. We partner with you across the omnichannel engagement value chain - from understanding your strategic objectives and defining personas to building and operationalizing a bespoke omnichannel roadmap and measuring outcomes. Through effective pricing strategy assessment and competitive engagement simulation, we simplify your medical omnichannel adoption and translate your medical imperatives into tangible, measurable outcomes.

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Intelligent MLR Solution

Indegene empowers life sciences organizations to deliver accurate, compliant, and impactful communications to healthcare professionals, patients, and stakeholders through a streamlined end-to-end MLR solution. By integrating deep domain expertise with proprietary AI technology and analytics-driven governance, we eliminate bottlenecks and enhance operational efficiency across medical, regulatory, and commercial functions.

At the core of our solution is a delivery team with practical hands-on subject matter expertise in managing the full spectrum of material review and approval, ensuring scientific rigor, regulatory compliance, and editorial excellence, including checks for language, style, and plagiarism. And, this team of experts harnesses Indegene’s NEXT MLR Review Automation Platform, powered by Agentic AI, which accelerates reviews, ensures consistency, and improves accuracy.

Indegene acts as a transformation partner, collaborating closely with clients to redesign MLR processes and unlock greater business value through intelligent automation and process innovation.

Medical Information and Communication

We enable customer-centric experiences through digital-first medical affairs operations. Our solutions span across the medical affairs operations spectrum from content creation, medical information (MI), material review and scientific publications to medical science liaisons (MSLs) and learning and development.

We personalize customer experiences through strategy, setup and end-to-end management of global and local technology-based MI as well as coordination of scientific publication across multiple therapeutic areas and languages. We apply technology to automate and modularize content creation and review, manage queries intelligently, personalize scientific exchange with physicians and develop self-service interfaces like live chatbots and MI web platforms.

Safety and Pharmacovigilance

We reduce the Total Cost of Safety operations by leveraging technology across the case processing cycle to automate high-volume case intake, data processing, quality checks, and medical review for submissions to health authorities, and therefore move from high-touch to low-touch case processing. We monitor, analyze, and report adverse event signals effectively to manage risks across the product life cycle and ensure persistent regulatory compliance.

Our team has deep expertise in life sciences risk management and an understanding of global safety practices to support your safety operations with seamless content collaboration, timely availability of high-quality submission-ready aggregate reports, provide insights from operations, risk evaluation and mitigation strategies.

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Pricing and Market Access

At MME, an Indegene company, our deep understanding of value perceptions of patients, providers, payers and physicians and rigor in primary and secondary research helps you optimize your pricing, reimbursement and market access strategies with data-driven insights. We have proprietary payer panels in both the US and Ex-US core markets consisting of current and former members of committees responsible for assessing clinical and economic value of therapies.

We bring in expertise to help develop the right pricing, reimbursement and market access strategies and tactical plans worldwide including, but not limited to, global and single country gross-to-net price planning, payer research, dossier development, creating value story decks and payer communication, and develop pricing benchmarks and strategies at all phases of development. Let us help you learn from our experience and profit from our thinking.

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Medical Writing

We author, edit and review regulatory, scientific and educational content for health authorities, HCPs and patients. Indegene’s medical writing team is comprised of physicians, PhDs and life sciences experts who produce submission-ready content of high quality, accuracy, clarity and consistency. Our capabilities span both Medical Writing and Regulatory Writing, ensuring that critical documents meet stringent compliance standards while effectively communicating scientific and clinical narratives. Leveraging AI/ML, we streamline content creation, analysis and review, enhancing overall quality and efficiency. This includes the recently launched NEXT Medical Writing Automation platform, designed to streamline complex medical and regulatory writing workflows with Generative AI - accelerating delivery timelines, improving consistency, and enabling scale.

Our commitment to excellence is bolstered by the recent acquisition of Trilogy Writing & Consulting GmbH (Trilogy), a company with over 22 years of experience providing medical writing services to the biopharmaceutical and medical devices industry. Combining Trilogy’s in-depth expertise with Indegene’s core capabilities, life sciences companies will benefit from partnering with a single service provider to deliver effective medical writing practices and outcomes at scale across the value chain.

Regulatory Operations, Publishing & Submissions

We apply domain expertise and fit-for-purpose technology to deliver end-to-end regulatory operations services, including consulting, regulatory intelligence and planning, dossier compilation, eCTD/NeeS publishing, electronic submissions, Clinical Trial Transparency (CTT), and Regulatory Information Management (RIM). Our experienced regulatory professionals ensure accurate, compliant, and on-time submissions to health authorities worldwide, while our proprietary planning and HA query management tools track evolving regulations, dynamically prioritize submissions, and predict potential queries—enabling faster approvals and reduced risk. Too often, submission solutions fall into one of two camps - tech-first with little domain depth, or expert-led but manually intensive. At Indegene, we bridge both. Our submissions management brings together deep expertise and an AI-powered NEXT Regulatory Submissions Planning that cuts submission timelines by up to 40%.

We extend this with end-to-end clinical trial transparency—covering compliant anonymization and redaction, clear lay summaries, and RIM modernization. Our consulting services focus on regulatory performance diagnostics, process assessment and re-engineering, digital transformation and data strategy, organizational design and governance optimization, and peer benchmarking. We are trusted by leading life sciences companies, including a Top 10 pharma managing submissions across 150+ markets, to deliver compliant, accurate, and on-time approvals with speed, precision, and reduced risk.

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Labeling, Artwork

We provide comprehensive label lifecycle management and artwork services to ensure 100% compliance, clarity, and consistency across global markets. From content development, competitor label intelligence, and variation management to packaging artwork creation, adaptation, review, and approval workflows, our processes deliver accuracy and efficiency at scale.

Learning and Development

We provide consulting and technology-led acceleration for learning and development requirements, to enhance business outcomes through custom-developed learning programs. We conceptualize, design, and develop smart and agile learning and development programs that align to the business goals of the enterprise. The curriculums are designed with a thorough skill gap and need analysis, and align to learning pedagogies and strategies.

We deliver the programs with a data-driven approach that uses technology to propel change management, peer learning strategies, adaptive micro-learning, and analytics-based learning experiences, alongside continuous measurement of learning effectiveness and ROI. Our proprietary technology uses innovative learning techniques like spaced learning and confidence-based assessments that help gauge the knowledge and confidence levels of the users in a gamified manner resulting in increased learning retention.

Health Economics and Outcomes Research (HEOR)

We reduce ambiguities and enable data-driven decisions with HEOR services including effectiveness studies, real-world data (RWD) collection, evidence generation, advanced health economic modeling and value communication. Our multidisciplinary team of clinicians, data scientists, statisticians and health economists enable healthcare enterprises to assess the impact of products on the quality of patient lives and physicians’ knowledge, as well as on organizational budgets and returns on investment.

We bring together deep domain expertise, mature processes and proprietary NLP/ML clinical and statistical algorithms to generate RWE from primary and secondary real-world patient data and perform effectiveness studies to enable informed market strategy.

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Digital Medical Equivalence

Digital Medical Equivalence leverages data, analytics and deep therapy area knowledge to enable market shaping and development processes for medical affairs functions. It analyzes scientific and medical communication interactions with millions of physicians and patients to derive insights that can inform decisions for relevant and personalized information to physicians and patients at a fraction of the cost. It understands medical interactions at the individual level and aligns those behaviors to an omnichannel strategic plan for a future ready medical affairs operation.

Generative AI

We guide life sciences organizations from Generative AI experimentation to full-scale implementation, leveraging deep expertise and strategic insight tailored to your unique needs. Our team of experts crafts personalized Generative AI solutions that drive measurable outcomes. Our Generative AI solutions seamlessly integrate into your existing tech stack, accelerating advancements across critical functions such as Scientific and Medical Content Development, MLR Review, Medical Information, Clinical Trial Operations, Regulatory Affairs, Pharmacovigilance and Learning and Development..

Our leadership in this space is widely recognized: HFS Research named Indegene a leader in Generative AI for life sciences, and Everest Group positioned us as a Leader in the Life Sciences Digital Services Specialists PEAK Matrix® 2024. We also won the 2024 Silver Stevie® Award for Technology Innovation in Healthcare, and the 2025 Stevie® Awards in Healthcare Technology and Artificial Intelligence for helping a Top 5 pharma scale GenAI for R&D medical writing with real-world impact, production-grade execution, and a governed, SME-driven ecosystem built for both speed and compliance.

Adopt technology to accelerate and scale medical outcomes

Personalize physician, patient and payer experience

We enable medical affairs organizations with core domain expertise and technology to deliver consistent and customized medical and scientific information

Reduce total cost of pharmacovigilance operations

We empower safety teams with insights and technology to proactively monitor, analyze and report adverse event signals and manage risks effectively

Improve success and speed of regulatory approvals

Our life sciences-contextualized technology across the product development lifecycle ensures 100% compliance in a complex and dynamically changing regulatory landscape

Case studies

Case Study

Medical Affairs

US Biopharma Uses GenAI for Standard Response Docs

Case Study

Regulatory Affairs

Global Biopharma Uses GenAI for ICS and PLPS

Case Study

Safety

Global Pharma's 3-Year Pharmacovigilance Roadmap

Case Study

Safety

Indegene Automates ICSR Compliance Monitoring Process​

Case Study

Regulatory Affairs

Indegene helps a top-5 pharma scale dossier submissions by 50x

Case Study

Regulatory Affairs

Improve efficiency of creating PILs

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