Industry
Life Sciences
Patient-centered Care Models Taking Center Stage in Life Sciences
Highlights
- Health authorities today are more open to structured dialogue and engagements through data-driven approaches, such as real-world data and real-world evidence to improve the reach of medicines. In addition, new treatment modalities, such as personalized medicines, and cell and gene therapies are gaining currency to address unmet needs.
- The increasing diversity of patients and the need for faster global access to medicines drive collaborative partnerships in the industry. Technology is leveraged for collective knowledge, leading to efficient navigation, streamlined processes, and harmonization of complex regulatory requirements.
- It is vital for regulatory affairs to foster equitable development, and regulatory affairs teams need to expedite regulatory submissions to health authorities.
- The focus is now on continuously improving submission timelines, enhanced success rates, and right-first-time quality applications, which requires combining regulatory affairs knowledge and experience with technology levers to provide faster and better submissions.
In this article
Overview
Ensuring compliance with health authority requirements throughout the drug product’s lifecycle is crucial for product approvals.
Pharmaceutical companies need to register medicinal drugs intended for human or animal consumption with the health authorities as per a country’s specific requirements. However, they face various challenges in meeting regulatory standards, generating high-quality dossiers with accurate safety and efficacy information, and maintaining complete regulatory data repositories.
Accurate data and knowledge management are critical, especially in regulated industries like healthcare and pharmaceuticals. Errors or inconsistencies lead to inefficiencies, delayed product approvals, compliance issues, and potential risks to patient safety. Ensuring proper documentation and adhering to regulatory standards is essential for smooth operations and maintaining trust in the products as well as the services. Regulatory chemistry, manufacturing, and controls (CMC), quality, and compliance functions within regulatory teams are the crucial pillars that organizations rely on to maintain product quality and compliance.
Managing deliverable cycle times is necessary to avoid delays in product development and ensure timely submissions to regulatory authorities, allowing patients access to new treatment modalities. Enhanced inclusivity of health authorities in initial submissions from sponsors by creating global dossiers is one of the key aspects of improving global access. Regulatory affairs facilitate this interface between companies and health authorities, assuring compliance and timely approvals.
Our solution
TCS provides regulatory affairs services to global pharmaceutical, biopharmaceutical, and biotechnology companies for drugs, biologics, medical devices, and combination products.
Our services encompass regulatory authoring, labeling, regulatory document publishing, submission publishing, lifecycle management, regulatory information management, regulatory intelligence, compliance, and regulatory support to quality and documentation support related to manufacturing services.
Our regulatory professionals and technology consultants, enabled by a seamless onsite-offshore working model, lead and drive regulatory submissions to health authorities worldwide. We ensure that our customers receive the most relevant data through effective and timely communication throughout a drug product’s lifecycle. TCS’ services are crucial to enabling new product launches and ensuring compliance for our customers’ existing products.
With a focus on regulatory strategy and data science and an elaborate understanding of the pharma industry, TCS is constantly developing and implementing automated and intelligent solutions for regulatory services. We provide advanced solutions for pharma majors through strategic technology alliances and partnerships. Our consultative and advisory capabilities enable the seamless adoption of new technology and platforms and harmonized processes for unified global operations.
Benefits
Our right-first-time delivery approaches and high-quality services make us the partner of choice for global pharma companies.
TCS helps navigate the complex regulatory landscape by focusing on the following aspects:
- Business process transformation: We deliver significant savings for our customers by optimizing their business processes and providing the capability to adopt newer technology solutions.
- Agile operations: Through an agile approach, TCS helps improve operational efficiencies and stakeholder collaboration across the regulatory function.
- Lean approaches: From high-quality deliverables and improved submission adequacy, accuracy, and compliance to reduced regulatory cycle times and costs, our services have immensely benefited several pharma companies the world over.
- Quality assurance (QA): Our QA team regularly performs internal audits to ensure quality and compliance across projects, guaranteeing project teams’ audit and inspection readiness.
- Customized solutions: TCS has built customized regulatory solutions to meet each customer’s specific needs and ensure compliance with regional and global marketing authorization requirements.
The TCS advantage
TCS’ regulatory professionals provide a seamless delivery experience to companies across locations in Asia Pacific, Europe, India, Latin America, and North America.
With over two decades of experience in the regulatory affairs domain, TCS has deep knowledge and intelligence on regulatory business processes, global health authority expectations, tools, and applications.
Given our elaborate technology investments, we are developing advanced GenAI solutions for efficient regulatory operations.
Our regulatory center of excellence (CoE) manages our teams’ regulatory competency development needs and creates knowledge assets to drive focused, quick learning and other continuous improvement objectives.
We share robust metrics with our customers, ensuring transparency. We facilitate regulatory training for our associates to upskill them and keep them informed on the evolving regulatory environment. Our governance structure – with clearly defined objectives – has been the main driver of our successful partnerships.
Cases in point: Ensuring adequate regulatory affairs support and continued compliance
TCS successfully implements end-to-end regulatory submission management processes for a large UK-based pharmaceutical company.
The pharma company wanted to improve process documentation for regulatory submissions management to ensure timely, high-quality submissions.
Offering a holistic solution, TCS placed regulatory associates at near-shore locations in the UK and offshore locations in India. Our regulatory SMEs and project teams created robust documentation on business processes, standard operating procedures, manuals, and workflows. TCS also created detailed training material for end-to-end regulatory submissions.
By adopting a methodical approach, our project teams met and exceeded quality and turnaround time expectations across all deliverables for lifecycle management activities, including license renewals, annual reports, labeling updates, periodic safety update reports, and responses to health authority questions.
TCS used automation solutions for quality and key performance indicators (KPI) monitoring, which ensured project success.
Our project team demonstrated a 20% improvement in training and mentoring time compared to the customer’s existing vendor for a similar scope. By streamlining operations, we observed a 30% improvement in efficiency, and regulatory submission management, and submission planning and authoring activities. Our efforts also helped the customer save costs significantly.
TCS provides regulatory affairs support to a top US biopharmaceutical company for quality and global manufacturing operations.
For over three years, a committed team of proficient TCS associates have been delivering unwavering support to this valued customer. We assist with various manufacturing quality and internal and external site operation activities, including the annual product review (APR), compendial compliance, manufacturing science and technology (MSAT) operations, change control management, artwork review, validation support, and deviation management.
Additionally, our team is responsible for authoring and executing change controls for the customer’s external manufacturing sites. Our team also tracks and coordinates upcoming stability studies, batch release activities, and regulatory requests between CMC groups, country regulatory affairs (CRAs), and contract manufacturing organizations (CMOs).
Over the years, we have used our scale, size, and global footprint in the regulatory compliance and manufacturing process. TCS supports over 65 of the customer’s global internal and external manufacturing sites. We replicated best practices based on our experience across similar and diversified life science services to standardize, optimize, and transform operations.
Through our consistent efforts and quality services, we have established a robust delivery framework, ensuring business resilience, performance-based service, and year-on-year productivity commitment to our customers. Our approach has helped the company create internal bandwidth for compliance, research and development, and techno-functional advancements, resulting in tangible and intangible benefits.
