2018-10-02 | Reducing the Complexity of Global Pharma Regulatory Compliance

First and foremost, a successful serialization program involves far more than just placing serial numbers on packaging -- regardless of the market. However, pharmaceutical companies that distribute in more than one country face significant regulatory compliance complexity, with each additional market adding another layer of challenges. Regulations differ between markets, and can change often enough meaning regulatory professionals must be prepared to adjust processes, procedures and filings...

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2017-03-17 | The Global Serialization Marathon

By Avi Chaudhuri, PhD, Senior Global Partner

We are currently in the middle of a regulatory marathon—one created to meet the country-by-country guidelines for drug packaging throughout Europe, USA, and several other countries. At Systech, we care about this because the technology platform of choice to accomplish regulatory compliance has been our primary focus for more than twenty years. Systech has been the global leader in serialization-based product traceability ever since the US FDA...

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