The life sciences industry has been grappling with narrowing margins, expiring patents, dwindling drug pipeline, price-sensitive markets, industry consolidation, and rising adoption of personalized medicine. as well as wearables. Some of the biggest challenges the industry faces are managing the cost of raw materials and the cost associated with regulatory compliance. With strict regulations that vary from country to country, it is important that as an organization, they ensure compliance, as even a small oversight can lead to millions in losses.
There has also been a surge in M&A/restructuring activities as stakeholders make efforts to revive margins by realigning the strategic focus. This combination of disruptive and legacy factors is driving technology needs among life sciences firms, which is translating into increased focus on analytics, infrastructure services, data consolidation, and application modernization efforts. As life sciences firms embark on their digitization journey, there has been a spike in the demand for digital enablers and tools that cater to specific value chain elements and help achieve desired business outcomes. Successful digital adoption would require life sciences stakeholders to transform their entire stack of services and adopt an integrated services strategy.
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Based on the extensive experience, YASH has developed a pre-configured Rapid Deployment Solution (RDS) built on the best practices with built-in GxP control specifically for pharmaceutical companies. YASH’s Pharma RDS solution helps transform the business by reducing Total Cost of Ownership (TCO), reducing regulatory compliance risks, robust quality management and assists in innovation and development. Find out more about our Pharma RDS solution.
Stringent quality requirements in FDA regulated industries maintain that appropriate controls and procedures be in place throughout a software/computer lifecycle. YASH brings a thorough understanding of business processes for the life sciences industry and provides a practical, risk-based approach to Computer System Validation (CSV). Our services enable customers to meet global regulatory requirements and help eliminate GxP compliance risk. YASH provides a broad range of CSV services, capabilities and tools for ERP Systems, Manufacturing, Laboratory, and Clinical Systems. YASH has highly qualified and experienced CSV Life Science domain consultants providing the most efficient and cost-effective CSV services. Find out more information about our CSV services
Introduction Radioactive materials are used in process industries for multiple purposes; a predominant use, however, lies in the Pharma industry. Radiopharmaceuticals have a very short, usable life of the radio-active product when compared to conventional pharmaceuticals. The shelf-life (expiry period) of a radioactive material depends primarily on the physical half-life of the radioisotope, the radiochemical stability and the content of the longer-lived radio-nuclidic impurities in the material under consideration as...Read More
It is no secret that the life science industry is always challenged globally by ever evolving stringent regulations. With the modernization of the life science industries, implementation of technology has increased. To prevent software malfunctioning and more importantly to ensure that the life science technologies are safe for patients, CSV is mandatory for all life science companies. Life science industry includes pharmaceutical, biotechnology, Clinical Services, and medical device manufacturing companies....Read More