Accelerating Oncology Submissions

The following elements allow pharmaceutical companies to be properly set up for success from the onset of any oncology or radiopharmaceutical program when partnering with the right CRO:

• Regulatory Compliance: MMS has supported countless NDAs with multiple pre-submissions waves and RFIs, serving the pharmaceutical industry as proactive strategists to comply with the current regulatory guidance from global health authorities.
• Expedited Programs Guidance: MMS has an extensive knowledge of expedited programs, oncology submissions, and RTOR rolling reviews. We can help you gain approval by:
  – Achieving initial designations for Fast Track and Breakthrough
  – Leveraging designations to optimize clinical development
  – Preparing for the challenging timelines associated with Priority Review, rolling submissions, and Advisory Committees
  – Sharing industry best practices from our history of submissions working with partners across the pharmaceutical industry as a CRO of choice
• Operational Excellence: MMS regulatory experts are placed on your program from start to finish to provide the continuity of services needed and to better align on messaging and program development.