Product Labeling in the biopharmaceutical and medical devices industry is a complex process that involves dealing with several dynamics, like constantly changing regulatory environment, ever-increasing transactions, nuanced regional requirements, and product-specific issues. This results in severe compliance, quality, and timeline issues.
To deliver value through innovative approaches to labeling challenges from outside its own environment and even outside pharma sector itself, Indegene has invested in creating unique solution models along with the support of an extensive team of domain expertise to resolve compliance and productivity issues across client organizations.
Indegene offers fully managed end-to-end labeling solutions that ensure efficient content management, streamlined workflow processes, and predictive compliance monitoring through the entire continuum across therapeutic areas and regions including developed markets (the US, Canada, EU, ANZ, and Japan) and emerging markets (Asia, AfME, and Latin America).
Indegene has been successful in implementing technologies in our client engagements,
resulting in huge cost and time savings. We are currently engaged in automating and developing content
models and running Structured Content Authoring (SCA), robotic process automation (RPA), Serialization
Identification of Medicinal Products (IDMP), and
e-labeling for future proof-of-concept initiatives for end-to-end life cycle through artificial intelligence (AI), machine learning, and natural language processing (NLP) technologies. This complete one-stop solution for an end-to-end labeling process will help meet the ultimate goal of simplified and efficient labeling operations decongesting crucial internal bandwidth, thereby increasing productivity, improving compliance, and eventually bringing down costs substantially.
Our differentiation lies in exclusive focus on the life sciences industry and a proven track record of partnerships by seamlessly integrating medical expertise, operational flexibility, modern technology know-how, and advanced analytics:
100% focus on the life sciences industry with deep domain expertise and regulatory understanding
Well-established core labeling, local labeling, and regulatory practices
Investments in transformational AI and machine learning platforms and solutions for scale, compliance, and efficiency
Track record of nearly a decade with multiyear engagements in labeling with global teams of pharmaceutical companies
Tailor-made operating models suiting your needs
Scalable team of professionals with deep scientific/medical expertise and experience
Global operating model built on industry’s best practices to deliver service excellence by ensuring global compliance, standardization, and cost-effectiveness
Ability to provide 24×7 support by working across time zones for seamless support
Indegene has extensively invested in harnessing modern technologies (AI, machine learning, etc.) to positively impact the traditional services and processes, including labeling with a dedicated innovation team (technology experts, product development, data scientists, analysts, annotators, and subject matter experts). Indegene has a robust framework in place to address the contentious issues faced by life sciences organizations. This enables us to offer solutions led by advanced medical expertise ably supported by technology-driven automation and productivity.
Initiatives like robotic process automation (RPA) have been key factors that Indegene has contributed to its client operations to handle repetitive, labor-intensive tasks, including data extraction, review, and management to help drive significant productivity and compliance across business processes. Indegene is working with top 5 pharmas through innovative incubation models that are operational centers to develop innovative solutions to the real-world business problems and many of them are in the proof-of-concept phase.
Indegene has a dedicated team of 250+ labeling experts with a cumulative experience of 200+ years. The team includes subject matter experts in labeling and artwork management, regulatory submissions, and pharmacovigilance (PV).
The team comprising labeling reviewers and medical reviewers has adept knowledge of the medical aspects, scientific perspectives, regulatory requirements, and marketing interfaces that prevail in modern strategic labeling and global labeling processes. All resources have extensive experience in working with tools and technologies related to structured content authoring, end-to-end workflow tracking, compliance management, enterprise document management, and document comparator systems.
Indegene has invested in building its own state-of-the-art Indegene Learning and Development Academy (iAcademy) which trains and develops experts on general and specific topics of Global Labeling, Regulatory, Safety, and PV curriculum. Indegene also exposes its people to continuous learning opportunities by enabling them to take up affiliated global certification courses, regulatory and PV conferences, expert speaker sessions, and so on.
Indegene works with its clients to ensure that quality plans developed are tailored to each engagement with defined parameters and supported by process checklists, work instructions, and tip sheets. The 360° feedback mechanism ensures appropriate flow of communication between the stakeholders with a well-defined escalation plan. The knowledge gathered through these global forums is stored in a centralized enterprise knowledge management repository that can be accessed to ensure best practices, knowledge frameworks, and guidance are followed for all our engagements, thereby providing enormous benefits to our clients.
A robust quality culture is established and practiced across our teams. Our process and quality management plans are compliant with the global and regional regulations/guidelines. With ISO and CMMI services-based quality frameworks, both process quality assurance and product/service quality control are ensured across all customer engagements.
Quality reviews and checks are critical in labeling. Indegene has established QC processes at each key step to ensure completeness and accuracy. These metrics and plans are mutually decided with the clients before we start any engagement. We build document-specific checklists and job aids which assist labeling managers to fulfill all the quality requirements. Indegene has also deployed knowledge-centralization measures to ensure consistency, repeatability, and scalability of quality labeling work.
We deploy dedicated program management office to oversee quality, training, and infrastructure to increase organizational responsiveness, knowledge retention, and sharing of best practices. The benefits to our clients include:
Minimal client "hand-holding"
Minimal investment of time and efforts in training and reviewing
Minimal time to get started and ramp-up
The key to creating or updating a core label is to have specific knowledge and experience of handling various stakeholders and information assets of pharma, and Indegene exactly has the best-in-class experience in handling the most important information of a product’s safety. We support our clients in reinforcing labeling and regulatory strategies by utilizing regulatory knowledge, labeling experience, and project management expertise to develop, review, and deliver a CCDS or RSI/CCSI across product types and classes.
Indegene is one of the first companies in the industry to execute the classic Hub model/localized operating model in the local labeling arena. Our teams of experts have deep experience across various portfolios like innovators, generics, vaccines, and devices, and so on and are well versed with local regulations due to dedicated resources assigned to a market/cluster of markets. We have extensive experience working with CCDS, USPI, SmPC, PIL, SPL-PLR, EU MRP, CP, and DCP procedures, hybrid scenarios, leaflets, inserts, and so on.
Being the pioneers of end-to-end local labeling operations, Indegene has successfully been able to bring out some of the best successful and long-lasting client engagements with 100% timeline compliance for client and regulatory bodies and >50% improvement in productivity and savings.
Indegene has 6+ years of experience in global labeling alignment projects, spanning 80+ countries, reviewing and delivering 18,000+ comparisons for alignment. Our services include review and update of reference labels, authoring and update of label justification documents and clinical overviews, and performing regular single comparisons (CCDS and local label), multiple comparisons (more than one local label and CCDS), hybrid comparisons (EU SPC, CCDS, USPI, and local label), regulatory submission-type comparison, and EU variations comparison. We have also delivered ADR frequency comparison and assessment for EU variations and other requirements, thereby helping them to assess the compliance levels and address them.
As compliance is the key for any labeling organization, Indegene understands and supports its various clients in assessing and achieving 100% regulatory compliance. Indegene does this in 3 steps:
Identify and fix compliance challenges by assessing current level of compliance and root cause for persisting issues
Build organization to achieve the desired compliance rates by consistently driving standardization across markets and brands
Drive cost-efficiencies and productivity through continuous improvement and higher performance assisted by automation for transactional activities
We have consistently been able to provide quality of more than 99% for labeling documents with an error rate of <0.5%. Our singular focus is on getting our reviews "Right First Time".
We have been able to help our clients bring harmonized content to its labels across markets and across products, which has minimized the risk of rejections of labels to the health authorities and to bring accurate safety information to the patients across the globe. We have been able to achieve this as a result of an established process of aligning the source label to its dependent label that is able to catch almost all of the deviation issues, operationalizing best practices, and hybrid deployment model that includes onsite and offshore specialists for round-the-clock coverage.
We have been able to boost the productivity of the review processes of our customers by over 30%. We have been able to achieve this as a result of continuous and nuanced training to our review specialists, deployment of trained subject matter experts, centralizing the operations of review processes, and contextualizing modern technologies to automate an increasingly significant portion of the review processes.
We have maintained a consistent month-on-month and year-on-year track record of 100% compliance on all our engagements not only for accurate content but also for adhering to Health Authority submission timelines. Our specialists have the knowledge of regulatory guidelines. Our specialists are regularly and continuously trained on ever-changing labeling and regulatory policies. We also engage closely with key personnel who are or have been involved in constituting regulatory guidelines.
Indegene has exceeded its client expectations through maintaining high-quality delivery as evident from zero critical findings in the audit and vendor assessments.