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On July 28, 2022, the EMA released an incremental update to the IDMP-SPOR implementation guide (IG). The latest version, 2.1.1, addresses a few…

Introducing innovative products across global marketplaces is imperative for life sciences companies to ensure profitability and maintain their…

For years, Regulatory publishing was done by manual tasks. Publishers used to work for hours formatting documents, generating Agency-compliant…

Life science companies face massive challenges while constantly staying ahead of dynamic Health Authority (HA) updates. In addition, it requires…

In addition to completing the requisite xEVMPD data submissions, life sciences organizations will now need to use a web-based application form…

The post-pandemic world is realizing that the intersection of technology and a traditional way of doing business already exists with us.

The world of life sciences is ever-changing and becoming more challenging, with fast-paced Regulatory guidelines being introduced frequently. Over…

While creating compliant packaging, controlling the labeling flow and its implementation through artwork, supply chain and printing involves…

As many of the Health Authorities transitioned from paper documentation format to the eCTD format, it is time for organizations to define key…