SOLUTIONS

Regulatory Submissions

Sponsors trust MMS with their global health authority submissions

Thank you… for helping us accomplish the key submissions for the program! We could not have achieved these milestones without your help and dedication along with round the clock service from you and your team.

VP, Regulatory Affairs

Emerging Pharma

MMS provides global submissions support that spans the entire spectrum of regulatory requirements, from the Investigational New Drug (IND) application stage through New Drug Applications (NDAs).

MMS combines deep regulatory expertise with innovative scientific approaches to ensure that your drug development process is efficient, compliant, and strategically aligned with standards set by the United States Food and Drug Administration (FDA) and other global health authorities. Our seasoned global regulatory professionals are adept at managing every aspect of the submission process. From the initial IND phase, where we guide you through the complexities of early-stage clinical trials, to the NDA/Biologics License Application (BLA)/Marketing Authorisation Application (MAA) phase, where we compile and submit robust evidence for product safety and efficacy, MMS offers unparalleled support.

With MMS as your submissions partner, you can navigate the regulatory landscape with confidence, knowing that your submissions are in the hands of experts committed to moving the industry forward, one approval at a time.

IND/CTA

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, pharmacovigilance (PV), medical writing, and transparency teams collaborate cross-functionally on each aspect of IND/clinical trial application (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.

NDA/BLA/MAA

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, central nervous system (CNS), and others.

OTC Switches and OMORs

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 Over-The-Counter Monograph Order Requests (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.

505(b)(2)

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’ craft 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.