An India-based leading Clinical Research Organization (CRO) was looking for Regulatory support with the creation of Structured Product Labeling (SPL) for the USFDA and CDSCO. The project presented several challenges such as:

  • Documents provided by the client had been last updated in 2015 and there were many validation gaps in them.
  • Freyr had to conduct an in-depth SPL validation for a US FDA-compliant SPL submission.
  • Freyr had to ensure that the data values were in accordance with the format (DUNS number, labeler code, etc).

Freyr’s Publishing & Submissions team had to showcase its technical expertise in content, artwork, packaging, and design activities. They were able to accomplish the task of preparing successful submissions in two (02) weeks’ time, as per the latest US FDA regulations; moreover, the customer gained cost benefits of more than 50%.

Download the proven case to explore how Freyr offered compliant Regulatory services and ensured timely SPL submission to the US FDA and CDSCO while adhering to the new guidelines and ensuring effective validations.