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Regulatory

Deep Regulatory Expertise and Life Sciences-Contextualized Technologies to Modernize Regulatory Function and Processes

Regulatory requirements for life sciences companies are becoming increasingly complex and stringent to adhere to, resulting in colossal delays and penalties for noncompliance. Simultaneously, keeping pace with the peaks in high-volume submissions is becoming ever more onerous to handle in-house, thereby, impacting the timelines for new product approvals and expansion into emerging markets. In addition, organizations are also grappling with the integration and management of internal processes and standards of their legacy products.

At Indegene, we understand the challenges of complying with the laborious and evolving regulatory requirements both in the developed and emerging markets. We partner with clients to support them with their Regulatory Affairs functions across the product development life cycle right from regulatory intelligence support to authoring of regulatory documents, submission management, publishing, and product life cycle management. Our service offerings span across a varied product line to include new chemical entities, generics, OTCs, biologics, medical devices, cosmetics, and nutritional products.

Through our fully integrated Regulatory Affairs functions, we help our clients with flexible outsourcing solutions that effectively reduce cost and time-to-market, enhance efficiency, and ensure compliance to bring maximum business value.

Our core differentiation lies in our proven track record of partnerships by seamlessly integrating regulatory expertise, operational flexibility, technology know-how, and advanced analytics:

  • A seasoned team of regulatory professionals with more than 10 years of regulatory experience across all major and emerging markets

  • Investment in transformational platforms and technology-enabled services to drive performance and regulatory life cycle efficiencies

  • A scalable, cost-effective global operating model built on industry’s best practices to deliver service excellence by ensuring global compliance, standardization, and cost-effectiveness

  • Flexible delivery options (onshore, offshore, and near-shore resource engagements) for superior efficiency, easy operations, and maximum value

  • Well-established clinical and regulatory practices

Key Outcomes
100%
Compliance to SOP and Regulatory Timelines
≥99.5%
Right-First-Time Quality Score
>40%
Decrease in Processing Time
>30%
Increase in Productivity

Indegene has a large talent pool with more than 15+ years of experience in the pharma, biotech, generic, and device industries. The Regulatory team consists of highly skilled, experienced, and result-oriented professionals who bring a blend of extensive regulatory experience, medical writing, and scientific expertise ensuring complete coverage of business needs. Our teams of senior regulatory specialists are active in several industry work groups such as Drug Information Association (DIA), The Organisation for Professionals in Regulatory Affairs (TOPRA), and Regulatory Affairs Professionals Society (RAPS), and over the period have accrued extensive expertise across the regulated and emerging markets for various therapeutic areas and product portfolios. Our experienced leadership team boasts of:

  • Expertise in drug development strategy and management of product portfolios for diverse client base

  • Expertise in filing dossiers and managing global submissions (USFDA, EMA – CP, DCP, MRP, NP, and ROW markets)

  • Certified expertise in several software applications such as docuBridge, eCTD express, and ISI toolbox, and so on.

  • Expertise in document authoring for early-stage and late-stage product development and life cycle management

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 Regulatory and Safety curriculum. Indegene also exposes its people to continuous learning opportunities by enabling them to take up affiliated global certification courses, regulatory and pharmacovigilance 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 360⁰ 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, therefore providing enormous benefits to our Clients.

Our dedicated Project Management Center of Excellence adopts state-of-the-art project management tools and methods to seamlessly execute regulatory projects with predictability and precision that meet both clients’ and regulatory agencies’ stringent timelines. Our project managers are trained to monitor individual project milestones, manage anticipated risks, measure performance, and identify areas for continuous improvement. With the help of technology, we build unique systems that help optimize processes, thus enabling operational and organizational success. We comply with industry-specific SOPs and ensure conformity to all applicable regulations.

Our medical writers are able to coordinate with biostatisticians, data management, and project team members to produce comprehensive, high-quality, submission-ready documents for all the stages of clinical development. The writers come from life sciences and medical backgrounds, with ample experience in clinical practice, scientific research, academia, and industrial services. They are well-trained under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and have years of experience in authoring, editing, and reviewing regulatory documents.

The services can be offered either as part of an extensive clinical trial program or as stand-alone services. We can support at any stage in the product development from Phase I to Phase IV and have experience in a diverse range of regulatory documents, including:

  • Clinical protocols, informed consent documents, and case report forms

  • Clinical evaluation reports (CERs) and certificate of suitability (CEP)

  • Investigator’s brochures

  • Quality documents – CTD Module 3 and CMC documents

  • Nonclinical and clinical sections of CTD Module 2 (2.2, 2.4, 2.5, 2.6, and 2.7)

  • Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE)

  • Nonclinical or clinical interim data summaries

  • Clinical study reports (CSRs) and patient narratives

  • Investigational New Drug (IND), New Drug Application (NDA), and annual reports

  • Safety data sheets (SDS)

  • Patient information leaflet (PIL), label and carton content, pregnancy and lactation labeling rule (PLLR) updates

  • Literature reviews

Indegene's publishing team is certified in several software applications used for electronic publishing and has extensive experience in planning, preparation, and publishing of premarketing and marketing applications, as well as subsequent life cycle submissions to support initial applications. Our team comprises life sciences experts and technology specialists who are adept at converting complex data across multiple global markets into well-formatted, regulatory-compliant documents under stringent timelines.

We offer both clinical and submission-level publishing support and can develop customized regulatory publishing deliverables using tools and processes from the client systems. The team has a deep understanding of the global regulatory guidelines and requirements and can support publishing in all formats that includes electronic (eCTD and non-eCTD electronic submission [NEES]) and paper submissions of drugs, biologics, and medical devices.

Our key offerings include:

  • Dossier compilation services for global (US – IND, NDA, ANDA, BLA, Annual Reports; EMA - CTA, MAA, PSURs; Canada – NDS, ANDS, SNDS; Australia – MAA; GCC – MAA) and emerging markets (LATAM, APAC and ROW)

  • Dossier compilation and publishing of CTD, eCTD, and NeeS modules

  • Paper to eCTD conversions

  • Scanning and legacy document conversions

  • Drug Master Files (DMFs)

  • Product life cycle support for variations, renewals, and annual reports

  • License renewal for ROW countries

With the new FDA Final Rule (42 CFR 11) that just came into effect since January 2017, and the phase-wise implementation of the EMA Transparency Policy 70 and EU CT Regulation 526/2014/EC fast approaching, the pressure to provide greater transparency that traditionally did not exist has unquestionably intensified.

At Indegene, we recognize the importance of clinical trial disclosure and, therefore, are constantly upgrading our disclosure services to help our clients stay ahead of the complex regulatory requirements. Our team of regulatory experts brings years of experience in managing clinical trial transparency information and processes for an entire drug/device development pipeline in a comprehensive and cost-effective manner.

We specialize in the following clinical trial transparency services:

  • Protocol registration and amendment maintenance in clinicaltrials.gov, EUDRACT, and other global registries and sponsor-specific websites

  • Clinical trial result posting in clinicaltrials.gov, EUDRACT, and other global registries

  • Redaction and anonymization of regulatory documents such as the protocol, clinical study reports, clinical summaries, and other common technical documents

  • Authoring lay language summaries of clinical trial results

  • Proactively track and analyze the global trial disclosure regulatory landscape and align the evolving reforms with internal best practices and standard operating procedures (SOPs)

Key Outcomes

Key Performance Indicators

Key Outcomes

Key Performance Indicators

Key Performance Indicators
Content Accuracy

We have consistently been able to deliver final documents with a content accuracy of more than 99.5% as the SLA of our error rate is limited at less than 0.5%. Our singular focus has always been on getting our reviews "Right First Time".

Timelines

We have been able to consistently maintain the regulatory submission timelines at 100% year on year. We have been able to achieve this as a result of a robust quality review and workflow tracking process, which enable us to deliver quality first-time documents and also helps us track and mitigate any risk toward the submission of the documents to the regulatory authority, operationalizing best practices, and hybrid deployment model that includes onsite and offshore specialists for round-the-clock coverage.

Timelines
Timelines
Productivity
Productivity

We have been able to boost the productivity of the review processes of our customers by over 40%. 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.

Compliance

We have maintained a track record of 100% compliance on all our engagements. Our specialists have the knowledge of regulatory guidelines, with a special focus on FDA/OPDP, MHRA/ABPI, EPA/EFPIA, and other local European national regulations. Our specialists are regularly and continuously trained on ever-changing regulatory policies. We also engage closely with key personnel who are or have been involved in constituting regulatory guidelines.

Compliance
Compliance

Real World Case Study