Life Sciences

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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

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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

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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

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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 […]

IDMP: It Deserves Many Purposes

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It’s a new year, and after a series of blogs last year where I delved into the finer nuances of IDMP, I believe it’s a good time to review just what it’s all about. IDMP (Identification of Medicinal Products – that set of ISO standards I keep talking about) began with a simple premise: Provide […]

FDA Demand Continues the Evolution to Supply Chain Transparency and Visibility

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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 […]

10 Reasons Why Labeling Should Be in Your Top New Year’s Resolutions

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The work involved in managing product labeling is astronomical – in fact I’d go as far as to say it’s analogous to the manufacturing process. From control of the process, to coordinating all the moving parts, to cross-checking content, to managing reworks and translations, to ensuring traceability and audit trails – it’s time-, labor- and […]

IDMP: Increasing Delays Mimic PIM?

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Before I go any further, let me answer the question in my somewhat tongue-in-cheek headline: No. IDMP (Identification of Medicinal Products) is not like PIM; it isn’t mired in controversy and stuck in idle. In fact, the situation with IDMP is quite the opposite to that of PIM (product information management). Yes, IDMP has suffered some […]

Tapping into the Power of a Global BPS Team

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Life sciences companies increasingly understand the power and value of partnering. But what does that mean when it comes to managing the publishing process? By Anja Westphal, Regulatory Engagement Management, CSC In her recent blog, Someone to Watch Over You: The Benefits of a Submission Manager, my colleague Usha Sharp described the role of a […]