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Top Tips – Building your ISO Quality Management System

Top tips for building your ISO Quality Management System for Pharmaceutical Companies A Quality Management System (QMS) is key for pharma companies and should encourage organisations to comply with ICH Q10 and ISO guidance. Pharmaceutical QMS must also accommodate unique industry requirements to achieve core quality principles and other requirements by providing all the features […]

Teva Turns the Corner

After a tumultuous year of ups and downs, Teva Pharmaceuticals seems to be slowly turning the corner. The Israel based company saw a significant downturn in performance during 2017 attributed in part to shortsightedness of trends in the market, too rapid growth and leveraging, and most critically, failure to diversify its portfolio. Its focus on […]

Digital Technology for Diagnosing and Treating Cancer

Early screening, diagnosis, and management of cancer improve patient survival and reduce symptoms. However, while some common cancers such as breast, prostate, and cervical cancers are routinely screened for, many others are currently difficult to detect. Consequently, they are often detected in the late stages, adversely affecting the patients’ survival probability. In recent years, digital technologies […]

Why the FDA Loves Complex Generic Drug Products

Key Points FDA Commissioner Scott Gottlieb has initiated multiple policy actions to simplify the approval pathway for generic drug products Commissioner Gottlieb hopes these efforts will improve access to medications and lower healthcare costs The FDA has placed special focus on “complex” generic drug products, which have traditionally been difficult to “genericize” New policies are […]

The Role of Human-Centric Design Thinking in Healthcare

By Karin Bauer, VP Client Services, SGK Health Healthcare is an empathy-driven industry. But as healthcare consumers seek to become more empowered, changes in healthcare information gathering and sharing across systems have created a disconnect between the quantity of information available to empower care choices and the quality of care that patients receive. To win consumer confidence […]