Regulatory Affairs Services
Regulatory experts at MMS are adaptive, organized, and equipped with vast regulatory knowledge.
MMS has a proven regulatory track record, providing global Regulatory Affairs Strategies and Services across a wide array of treatment areas and disciplines.
MMS Regulatory Affairs Services is focused on supporting companies as they advance their drug, biologic, device, and/or combination products through regulated pathways from development to commercialization. The path to success varies by Sponsor, product, and region. Thus, MMS provides bespoke solutions to fulfill organizational business goals for a wide range of pharma companies from industry giants to biotech startups. MMS Regulatory Operations colleagues are industry-trained experts skilled at managing, preparing and submitting a diverse array of regulatory submissions to global health authorities. MMS Regulatory Affairs Managers ensure compliance and provide the critical interface between the organization and global health authorities; while our Strategists formulate, direct, and implement innovative and pressure-tested strategies and streamlined development plans that account for the minimum available data and acceptable levels of organizational risk. MMS values and cultivates long-term client relationships and strives to function as a value-added extension of the Sponsor’s regulatory team framework.
Regulatory Strategy Consulting
MMS strategists provide regulatory intelligence through the collection, analysis, and interpretation of publicly available and experience-based regulatory information and will work with you to create an actionable regulatory strategy to support optimal progress/development.
Phase Specific Strategy
- Early Development Strategy Consulting: Consulting on early clinical development from preclinical/first in human to prior to end of phase 2
- Clinical/Late-Stage Strategy Consulting: Consulting on clinical development from Phase 2 to Marketing Application
- Establishment/Lifecycle Consulting: Consulting on product launch, maintenance, or further development after product licensing
Expedited and Incentivized Development Strategy
- Expedited Development Strategy Consulting: Consulting on FDA (fast track, breakthrough/RMAT, priority review, accelerated approval) and EMA (PRIME designation, accelerated assessment, ATMP development) programs.
- Incentivized Development Strategy Consulting: Consulting for development programs of eligible drugs for orphan, pediatric, QIDP, LPAD pathways/designations and other FDA and EMA programs eligible for incentives
Pediatric Disease Development Strategy
Includes support for development of waiver or deferral requests, paediatric investigational plans (PIPs) and pediatric study plans (PSPs), incorporation of agency feedback, and pediatric written request (PWR) acceptance, amendment, or annotation to support an exclusivity claim.
Label Development Strategy
- Assessment and evaluation of predecessor labeling
- Discovery questions to contribute to identification of applicable labeling content
- Advising on labeling to support clinical trials
- Early (aspirational) label development
- Label development in support of a marketing authorization (prescription or over the counter [OTC]),
- Label development in support of a 505B2 or ANDA (FDA) or Hybrid, Variation, or Extension (EMA),
- Other post-marketing label updates,
Strategic Support for Meeting Requests and Packages
Includes preliminary communications with health authorities, preparation of meeting questions and rationales, assistance with meeting packages, meeting preparation, interpretation of responses from health authorities and follow-up
Related Client Case Studies
Regulatory Affairs Management Support
A global regulatory affairs manager stepped in to manage a Sponsor team while their leader was on maternity leave. Under the MMS expert’s leadership the overall health of the established products programs were maintained, and all required submissions were made on time and met FDA standards for quality and content
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Regulatory Affairs Management
MMS Regulatory Affairs Managers are an extension of Sponsor regulatory affairs teams. They are assigned to specific products and applications and work with Sponsor teams to execute regulatory activities and facilitate optimal progress/development.
Agency Representation and Regulatory Program Management
In addition to providing regulatory strategy consulting, these regulatory affairs managers are assigned as the actual product lead or lead for a specific submission type. Team members are responsible for
- communication of regulatory requirements and provision of status updates to stakeholders in the Sponsor company
- development of Module 1 content required for health authority interactions
- review of required regulatory documentation and files created by other functional lines
- representation to and interactions with the health authority(ies) on behalf of the Sponsor
Regulatory Affairs Submission Lead
Leads the team in preparation and execution of large and/or complex dossiers
Module 1 as a Service
Regulatory Affairs Managers and strategists can create regional, Module 1 documentation and provide the team with guidance on the content and format needed to support key interactions with global Health Authorities.
Industry-trained experts at MMS are skilled at managing, preparing, and submitting a diverse array of regulatory submissions to global health authorities, serving as an extension to the sponsor team. 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.
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 reinforcements to face any possible delays or risks that may set back the submission timeline. Our proven process ensure 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.
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 intent to submit applications, meetings and briefing packages 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 suits best. Example: Preparing the native word documents to enable rendering of automated submission-ready documents. Robust QC process ensuring PDF navigation and validation. Customized submission ready checks for anonymized or document for publication.
Submission Publishing and Delivery
MMS experts provide end-to-end support from content plan preparation, document procurement, submission outline, validation, and quality control. Publishing Specialists build submissions in an eCTD Publishing Tool and will ensure the submission passes technical validation. Our team can perform the heavy lifting and coordinate the submission review by sponsors, and dispatch. Our expert MMS team has submitted over 2,450 submissions over the last 3 years inclusive of all dispatches. Currently we are maintaining over 90 investigative, marketing, and master file applications (CTA, IND, NDA, ANDA, BLA, NDS, SNDS, MAA, DMF, ASMF). MMS has supported submissions in the US, Canada, AU, Swiss, EA/EU, UK, and GCC regions.
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
Our global teams have access to a wide variety of agency electronic portals and can dispatch submissions round the clock including gateway portals such as FDA, Health Canada, EMA, MHRA, IRIS, CTIS etc.
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 ensuring compliance to MMS and/or sponsors’ archival processes.
Regulatory Information Management
MMS has a well-trained and experienced team that supports regulatory information management. Our RIM services include creation of submission records along with archival process, Object creation and management (such as Events, Activities, Applications, Regulatory objectives and Registrations) as well as data migration activities. Sponsors are inclined on using systems that enable 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 sponsors regulatory archival needs. Our specialists can help sponsors navigate identifying the gaps, setting up structured and logical processes, assisting with developing SOPs and guidance materials, and training different vendor teams.
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