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The life sciences comprise the fields of science that involve the scientific study of living organisms, such as microorganisms, plants, animals, and human beings, as well as related considerations like bioethics. While biology remains the centerpiece of the life sciences, technological advances in molecular biology and biotechnology have led to a burgeoning of specializations and new, often interdisciplinary, fields.
Life Sciences is helpful in improving the quality and standard of Life. It has applications in health, agriculture, medicine, pharmaceutical industry and food science industry.
The following are the major categories we are ready to provide the services:
Life science companies are facing a growing number of business and regulatory pressures fuelling the need for business transformation. Patent expiration, mergers & acquisitions, organizational restructuring, downsizing, and budget cuts are clear indicators that change is constant. Moreover, electronic medical records, and a more conservative approach to patient safety and drug/device approvals is rapidly changing the way life science companies do business.
Covalent’s Life sciences practice leverages its combined strengths in FDA compliance, IT and domain expertise, to provide business transforming consulting services and solutions to the life sciences industry. With our unique business model of integrated IT and operations, our high-end services tailored to the life sciences value chain, and our three decades of life sciences experience, we help our clients manage key industry challenges like:
Our core Life Science service offerings include business transformation solutions providing lower costs and enhanced service through improved governance & compliance, technology integration, and collaboration with partners. Our market leading outcomes based relationship model includes an integrated IT and operations service model specifically tailored for pharmaceutical, medical device, biotechnology and clinical research organizations.
Research Accelerator: Our Research Accelerator for R&D provides clients an innovative architecture for accelerating the drug development lifecycle while rationalizing the IT portfolio. The solution consists of a pre-configured hosted platform of the Oracle Health Sciences suite of products together with an outsourced services component. The Research Accelerator solution is designed to provide pharmaceutical companies access to a low-cost operating model with next-generation technologies.
Quality and Regulatory Compliance: We are supporting clients in the development of quality system policies and guidelines, regulatory interpretation, and the selection and implementation of enterprise IT systems that help support quality control testing of raw materials, in-process and finished goods. We work with clients across the regulatory spectrum to build integrated compliance philosophy for Regulations including but not limited to Sarbanes-Oxley (SOX), Health Insurance Portability and Accountability Act (HIPAA), 21 CFR Part 11, and GxPs.
Computer Systems Validation: We offer risk management and regulatory compliance efforts conforming to GxPs and 21 CFR Part 11 as integral components to our clients’ computer system validation approach. Our managed CSV center approach with lean compliance and risk based principles help to reduce the overall cost of compliance.
Life Science Analytics: Our differentiated Business Intelligence solutions like clinical dashboard, Pharmacovigilance dashboard, Signal Intelligence PV™; annual product review reports and sales analytics provide decision support across the life sciences value chain.
Product Engineering: Our product engineering group has extensive expertise in undertaking end-to-end product development right from Mechanical Design, Electronic System Design & Development and Application Development and all associated phases of regulatory document preparation.