Global Regulatory Operations

Our skilled team of experts prepares eCTD-ready documents using advanced automation, ensuring minimal effort and maximum quality. Our published documents comply with global regulatory requirements with enhanced submission navigation, aiding agency reviewers. Native files are processed to ensure submission readiness, including tasks such as bookmarking, linking, OCR, scaling, updating document properties, and optimizing. This process supports complex documents like Risk Management Plans (RMPs), Case Report Forms (CRFs), and Clinical Study Reports (CSRs) with enhanced and automated publishing capabilities.

We are proficient in a wide variety of document management and regulatory information management (RIM) systems that Sponsors utilize, and we offer customized services tailored to meet their specific needs. For instance, we prepare native Word documents for automated rendering into submission-ready formats. Our robust quality control (QC) processes ensure accurate PDF navigation and validation, and we have specialized checks for submission readiness, including anonymized documents and those intended for public disclosure.

MMS’s experts provide end-to-end support from content plan preparation, document procurement, submission build, validation, and a 100% QC check. Our adaptable and proven processes, combined with our commitment to KPI-driven quality deliverables, ensure that our specialists generate submissions of the highest quality. Our project leads take on the critical task of coordinating the submission review with Sponsor teams, seamlessly addressing client requirements to ensure a smooth submission process.

From document authoring to compilation, MMS proactively engages with Sponsor teams to streamline activities, incorporate cross-departmental efficiencies, and simultaneously build multiple health authority applications, ensuring smooth regulatory submissions worldwide. Our global teams are always prepared to accommodate possible delays or risks that may set back the submission timeline. Our proven process and extensive experience ensure maximum reuse of published files and submission dossiers with minimum effort to clone and submit to diverse global regions. Your MMS regulatory colleagues continuously monitor for risks and anticipate regulatory issues, proactively addressing them to ensure submissions are prepared and submitted according to, or ahead of, the Sponsor’s or agency’s timeline.

Maintain the most up-to-date documents and associated information for your application in one place, ensuring every health authority has what they need at all times. This includes ongoing maintenance of all future sequences, such as amendments, supplements, variations, Ad-Promos, SPLs, and more.

Our global teams are experienced with most major agency electronic portals, enabling us to dispatch submissions around the clock. This includes gateway portals such as the United States Food and Drug Administration (FDA), Health Canada, European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), Interactive Regulatory Information System (IRIS), and Clinical Trials Information System (CTIS), among others.

We understand platforms from simple document sharing systems to advanced RIM solutions for document management and submission archival. Our specialists support multiple document management systems and provide custom support ensuing compliance with MMS and/or Sponsor’s archival processes.

The MMS team is well-trained and experienced and supports several RIM systems for our Sponsors. Our RIM services include the creation of submission records along with the archival process, object creation and management (such as Events, Activities, Applications, Regulatory objectives, and Registrations), as well as data migration activities.

Sponsors are inclined to use systems that enable a centralized process to plan, manage, and track regulatory data, documents, and activities. Our teams leverage knowledge gained from working on different RIM systems to provide dynamic support and comply with the Sponsors’ regulatory archival needs.

MMS regulatory specialists can help Sponsors identify gaps, set up structured and logical processes, develop standard operating procedures (SOPs) and guidance materials, and train different vendor teams.