Regulatory Submissions

Small sponsors can face major challenges when managing complex multinational clinical trials. Often, the long-term strategy gets lost in the shuffle of the day-to-day operational needs of the actual trial.

MMS is micro-focused on data and macro-focused on benefit-risk. This means that our biometrics, data science, quality, regulatory, PV, medical writing, and transparency teams collaborate cross-functionally on each aspect of IND/CTA preparation and maintenance as a micro-focus, while also ensuring that the evolving benefit-risk profile remains optimal for decision making as a macro-focus through continuity of support, therapeutic area expertise, and extensive regulatory experience.

Sponsors building their first Marketing Application submission must simultaneously face the challenge of creating a file-able, complete submission while also ensuring that all regulatory queries are addressed and anticipating any future information requests or potential advisory committee interactions.

For multinational submissions, MMS is micro-focused on data and macro-focused on benefit-risk. We are uniquely experienced in marketing application preparation across all service lines, ensuring a detailed approach to submission preparation that has resulted in zero refusals to file (micro-focus). Because of our strengths, MMS has significant expertise in preparing pharmaceutical and biotech sponsors for complex accelerated drug approvals, rapid priority review, and single pivotal submissions, as well as the rigors of information request response and advisory committee preparation (macro-focus), including several first-in-class applications in areas such as rare disease, oncology, CNS, and others.

Navigating the Over-The-Counter (OTC) regulatory pathways can be complex. With MMS, you can confidently bring your non-prescription drug products to market. Our regulatory experts provide specialized strategy and consultation to determine the best pathway for your OTC monograph request, ensuring thorough and compliant submissions for both Tier 1 and Tier II OMORs.

Additionally, we offer comprehensive support for FDA interactions, from health authority meetings to responding to additional data requests, streamlining your regulatory
processes and minimizing risks.

MMS provides expert support for 505(b)(2) submissions to the FDA, offering a streamlined pathway for the approval of new drug applications that rely on existing clinical data. Our team of regulatory specialists crafts tailored strategies to optimize your submission, ensuring comprehensive and compliant documentation. From conducting gap analyses to identifying necessary bridging studies, MMS manages every aspect of the submission process, including interactions with the FDA, to address any queries and expedite approval.

With a science-driven approach and robust data analytics, MMS helps you efficiently navigate the complexities of 505(b)(2) submissions, bringing innovative therapies to market swiftly and effectively.

Download our 505b2 whitepaper for more information.