Life Sciences

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Confronting the Winds of Change Across the Life Sciences Value Chain

The life sciences industry is up against some intense headwinds: declining market access, patent expirations, rising research and development (R&D) costs, pressure to ensure patient access; reimbursement barriers; and ever-increasing regulatory demands. Countering those challenges, however, are some exciting developments, such as growing global demand for healthcare opportunities in emerging markets alongside advances in medical […]

The Unknown Unknowns of Product Labeling: Are You Compliant?

Are you compliant? That’s a question that keeps regulatory affairs executives up at night, particularly in light of increased responsibilities and prosecutions. Where this question becomes even more difficult to answer is with labeling, since this is an area that traverses so many parts of the enterprise. Among the factors regulatory affairs must contend with […]

Getting an Early Start: Taking a Holistic Approach to Product Labeling

When pharmaceutical companies think about labeling, the assumption is that it begins with the marketed product. So the focus has typically been on managing the labeling text for post-marketing activities — artwork, packaging, etc. But it’s during the clinical trial phase that the company core data sheet (CCDS) should be developed and then updated periodically, […]

From Ad Promo to RPS – DIA Turns Focus on Being Prepared

Changing submission requirements come thick and fast for life sciences companies, putting regulatory departments under continuous pressure to stay one step ahead. There are a number of issues such departments will have to tackle now and in the future — from new electronic Common Technical Document (eCTD) requirements to the adoption of new standards. By […]

Transforming the Regulatory Environment Through as-a-Service

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The cloud is gaining huge ground across all industries as companies seek greater flexibility and reduced costs. Cloud can transform the way life sciences companies maneuver the changing regulatory landscape. But putting an as-a-service or cloud solution in place requires careful consideration, including identifying the stakeholders, defining your reason and goals, establishing a clear plan, […]

From Small to Large: Getting the Most from a BPS Engagement

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The submission management needs of companies vary significantly, particularly when it comes to size of the company. Deciding to work with a business process services (BPS) partner to implement agile workload management practices, therefore, should take those different requirements into account. By Marcy Miller, Principal, Regulatory Solutions and Services, CSC A small company with few […]

Providing Clean Datasets: The Benefits and Challenges of SDTM

There’s no doubt that the data standards body Clinical Data Interchange Standards Consortium (CDISC) has benefited both industry and regulatory authorities by standardizing the management of clinical trial data. But it’s fair to say that significant complexities are involved in converting data to the CDISC standards. By Han Zou, Manager, Biometrics and CDISC, CSC Let’s […]

Five Steps to Easing Your Path to eCTD Submission

Fifteen years after its release it may seem as though there’s not much you don’t know about the electronic common technical document (eCTD), but 2017 is a crunch year for electronic submissions and you need to be prepared. By Jennifer Tucker, Regulatory Affairs Manager, Business Process Services, CSC Beginning in May 2017, all marketing applications […]

From Branded to Generic – Staying on Top of Labeling Changes

For companies with marketed medicinal products, it would be difficult to imagine a time when labeling changes or updates wouldn’t be occurring. Since labeling requirements extend to any and all written, printed or graphic material associated with a product, this necessitates a seemingly endless review cycle to ensure that appropriate changes are implemented whenever there […]

FDA Demand Continues the Evolution to Supply Chain Transparency and Visibility

How quickly would you be able to respond to notification of an illegitimate product in your supply chain? Or perhaps more to the point, just how good is your visibility into your supply chain? By Rick Ruiz, Partner, Life Sciences, CSC The US Food and Drug Administration has continued its push toward requiring greater visibility […]