Case Study: Fast Track Designation

Challenge:

Small Pharma Requests Regulatory Writing Support for Anti-Infective Agent

A small pharma company was seeking a Fast Track designation for their anti-infective agent to provide more frequent FDA interaction and a rolling review of program submissions.  Also, as part of the Pediatric Research Equity Act, the anti-infective program was required to have a plan for pediatric studies prior to the NDA submission. They were in need of regulatory writing support for the submission documents, including a Fast Track Designation request document and Pediatric Study Plans for the US and EU markets, including a calculation for permitted daily exposure.  The sponsor team was looking to supplement their internal team with the appropriate resources who had expertise with these particular types of regulatory documents, as well as resources with therapeutic area knowledge and experience.

MMS Solution:

MMS Provide Regulatory Writing Resources to Support Sponsor Team

MMS was able to build a specialized team to support the unique requirements of these critical documents.  MMS leveraged a large database of specialized consultants to identify a regulatory strategist with experience in Fast Track submissions who helped to define requirements and strategy for the document content.  MMS also provided a pre-clinical toxicology specialist with experience in anti-infectives that was able to review toxicology and exposure data to strengthen the scientific arguments within the documents.  The team was led by MMS regulatory medical writers, who streamlined the content to align with the submission messaging and strategy, ultimately producing a high quality submission package.

Outcome:

Collaboration Resulted in a Successful Approval

The Fast Track designation was approved, and the MMS team was also involved with agency responses to help the sponsor design and develop their clinical program to support the pediatric population.

Regulatory Submission Support Based on Strong Science and Strength of Process. We Do Data Best!

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