Regulatory Operations
Our proven processes and tools are designed to produce high-quality submissions.
MMS experts can support all major submission types.
Regulatory Operations
Industry-trained experts at MMS are skilled at managing, preparing, and submitting a diverse array of regulatory submissions to global health authorities. Our team is committed to providing sponsors with personalized, directive, and forward-thinking end-to-end regulatory management support by serving as an integrated representation to Sponsor teams. Throughout the product life cycle, MMS experts provide high-quality and region-specific regulatory submission support using validated document management systems, gold standard eCTD publishing and validation systems, and on-the-ground support with certified local partners. MMS has supported submissions in the US, Canada, AU, Swiss, EA/EU, UK and GCC regions.
From preclinical to late-stage commercialization and global alignment of submissions and dossiers, MMS provides:
- Early-stage regulatory operations, including applying for application numbers, filing an intent to submit applications, meetings and briefing packages to support, and advisory meetings
- Clinical development regulatory operations and global submissions of study authorization applications, including initial study applications and amendments; scientific advice submissions; special designation submissions like fast-track designation, and special protocol assessment requests
- Marketing authorization, responses to requests for information, and post-approval life-cycle management, including initial applications or amendments and the maintenance of approved marketing applications marketing authorization including, Ad-Promo and SPL submissions
Regulatory Document Publishing
In compliance with regulatory authority requirements, Regulatory Operations prepares documents to heighten the navigation of the submission as an aid to agency reviewers. Native files are processed for submission readiness, including bookmarking, linking, OCR, scaling, updating document properties, optimizing, etc. Supporting complex documents such as RMPs, CRFs, CSR, etc., with enhanced and automated publishing capabilities. We understand a wide variety of document management and RIMS systems that Sponsors use and provide customized services that suit the best. Example: Preparing the native word documents to enable rendering of automated submission-ready documents. Robust QC process ensuring PDF navigation and validation. We have customized submission ready checks for anonymized or documents for publication.
Submission Publishing and Delivery
End-to-end support
MMS experts provide end-to-end support from content plan preparation, document procurement, submission build, validation, and 100% quality control check. With our adaptable, proven processes, and KPI supreme quality deliverables, our specialists ensure the submissions are generated with the utmost quality. The project leads perform the heavy lifting to coordinate the submission review with Sponsor teams and seamlessly address client requirements prior to submission.
During the submission authoring and compilation process, MMS proactively engages using proven processes to streamline activities, incorporate cross-departmental efficiencies, and build multiple health authority applications in parallel to execute regulatory submissions across the globe. Our global teams are always prepared with reinforcement to face any possible delays or risks that may set back the submission timeline. Our proven process ensures maximum reuse of published files and submission dossiers with minimum effort to clone and submit to diverse global regions. Our tenured colleagues continuously monitor for risks and anticipate regulatory issues to proactively address and ensure submissions are built and submitted per Sponsor’s/agency’s timeline, if not sooner.
eCTD Lifecycle Management
Ensure the health authority has the most up-to-date documents and associated information for your application in one place with ongoing maintenance of all future sequences, including amendments, supplements, variations, Ad-Promos, SPLs, etc.
Submission Delivery
Our global teams have access to a wide variety of agency electronic portals. We can dispatch submissions round the clock including, gateway portals such as FDA, Health Canada, EMA, MHRA, IRIS, CTIS, etc.
Document Management
We understand platforms from simple document sharing systems to advanced RIMS solutions for document management and submission archival. Our specialists are well versed in using multiple document management systems and provide custom support ensuing compliance to MMS and/or Sponsor’s archival processes.
Regulatory Information Management
MMS has a well-trained and experienced team that supports regulatory information management. 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 are able to leverage the knowledge gained from working on different RIMS systems to provide dynamic support and comply with the Sponsors’ regulatory archival needs. Our specialists can help Sponsors identify gaps, set up structured and logical processes, develop SOPs and guidance materials, and train different vendor teams.
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