SOLUTIONS

Accelerating Oncology Submissions

The Oncology & Radiopharmaceutical experts you need.

MMS did a great job leading the Oncology label and provided wonderful regulatory guidance. The MMS team crushed it and the outputs were flawless.

Director, Medical Writing

Oncology Sponsor

Oncology drug development is rapidly advancing, and MMS is here to help advance your regulatory submissions with integrated and flexible services spanning across all phases of development. There remains an unmet medical need for cancer patients and continued clinical research. Early engagement with global health authorities is critical in aligning on the clinical development plan.

Navigating oncology submissions has a unique set of challenges and having the right CRO team can help you meet the demanding timelines and rapid review cycles needed in Real-Time Oncology Review (RTOR) submissions. Our flexible and adaptive team has the expertise across a range of oncology therapies to ensure this happens.

Additionally, radiopharmaceutical clinical studies require a personal approach to ensure successful submissions, and MMS can help you navigate the complex regulatory requirements by providing expertise from proof-of-concept to approval.

Why Should Pharma Companies Be Proactive?

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.