Clarivate Plc, a global leader in providing trusted information and insights to accelerate the pace of innovation, has announced the enhancement of Cortellis CMC Intelligence™, the world’s only organised, timely and accurate source of Chemistry, Manufacturing and Controls (CMC) regulations and local practices. The addition of new biologic CMC content and features will support pharma, biotech and generics organisations in their quest to efficiently and accurately plan and prepare their CMC regulatory dossier submissions.
During these unprecedented times, researchers across the healthcare continuum need to connect the dots across multiple data points to enable the development and distribution of life-saving therapies. Most urgently, drug developers need practical solutions to support the manufacturing and global distribution of novel COVID-19 vaccines. In this new age of expedited drug development, Cortellis CMC Intelligence is a single platform solution for efficient identification, tracking, and comparison of CMC requirements, for all drug types, across the globe.
CMC and regulatory professionals are challenged to find all necessary requirements for successful drug filings, culling through volumes of often regionalised and siloed data and insights. Critical pieces of information can be overlooked and result in delayed drug approvals and costly re-submissions. According to recent studies, 18% of total R&D expenditure is spent on CMC activities conducted to optimise, scale-up, and validate the processes and technologies for transfer to manufacture and all Quality Assurance, Quality Control, and CMC support activities.
CMC and regulatory professionals risk spending significant time and resources preparing dossier submissions that are potentially based on incomplete or outdated CMC requirements. Studies show 50% of drugs submitted for approval from 2009-2012 were rejected. Of those drugs, nearly 12% were rejected due to CMC issues, with 18% of resubmitted drug applications delayed again due to CMC issues. Five percent of all drugs are never approved due to unmet CMC requirements. These points further support the need for more confident and efficient CMC regulatory dossier planning to ensure the optimised use of resources and support the submission of timely and accurate drug filings and approvals.
Cortellis CMC Intelligence Small Molecules curates and tracks official CMC regulations and local practices for more than 130 countries, territories and organisations with more than 25 product and related regulatory filters based on eCTD structure, over 800 source documents with citations, over 170 links to Cortellis Regulatory Intelligence, providing access to expanded detail. Cortellis CMC Intelligence Biologics will address CMC regulations for over 60 countries. The addition of biologics CMC requirements to the already robust library of small molecule content represents just one of the many investments Clarivate has made – and will continue to make – to expand and enhance the Cortellis suite of life science intelligence solutions. It is a key component of the comprehensive Cortellis suite of life science intelligence that allows pharma, biotech and generics companies to more comprehensively research and analyse critical drug development data to support the entire drug lifecycle. Additional content will be added throughout 2021 and beyond to further aid CMC and regulatory professionals CMC regulatory dossier submissions planning.Click here to read the original press release.