ANDA Submissions for a US-based CRO

ANDA Submissions for a US-based CRO

ANDA Submissions for a US-based CRO

  • Service Category: Authoring Services

Situation

The client was a US-based CRO acting as an US Agent for a Korea-based pharmaceutical company to submit three ANDAs for sterile injections (three different Active Ingredients). The client had four members managing the ANDA submissions, including pre-application inspection and pre-submission facility correspondence. A month before the first submission, one of the team members resigned and a second went on maternity leave, leaving the team in a panic. 

Solution

The client contracted Spark CMC for six months to assist with submission delivery. 

Call to Action

Spark CMC met with the client team to understand their immediate delivery needs. We then worked independently to deliver items, meeting with the team on a regular basis to ensure alignment for a timely delivery. Over six months the client team travelled to Korea multiple times to work with the manufacturing site while Spark CMC stayed in the US to provide needed support with minimal supervision and training to finish the time-sensitive submissions.

Results

Thanks to our ability to fill the staffing gap with zero training time, the client submissions were submitted on time–keeping their Korean sponsors pleased and ready to continue their partnership.