Regulatory Operations

MMS has the staff, technology and processes to deliver high quality, compliant electronic regulatory submissions

Regulatory Operations Staff

MMS has an experienced staff of industry-trained professionals to manage all aspects of electronic regulatory submissions. Our staff is located globally to support around-the-clock processing and quick turnaround times. MMS Regulatory Operations staff include:

  • Global Submissions Managers - global submission leadership and coordination for larger applications and applications filed in multiple regions or for projects that involve coordination of content from multiple CROs/consultants
  • Regulatory Operations Associates – submission project planning support and coordination of document and submission publishing, agency dispatch and regulatory document management and correspondence tracking
  • Document Specialists – formatting expert that ensures style guide and submission ready standards have been applied to Microsoft Word documents

Submissions Technology and Systems

MMS provides high quality and region specific regulatory submission support using validated document management and eCTD publishing systems. Throughout the submission authoring and compilation process, we proactively use our established systems to streamline activities, incorporate efficiencies, and work on multiple applications types in parallel to meet regulatory submission strategies.

We use a SharePoint-based document management system to manage, organize and connect regulatory documents in a compliant, efficient and easy to use way. This document management system provides support for the whole document lifecycle from the inception and authoring, up to the submission and archiving of regulatory documents.

MMS uses Lorenz Docubridge to build, view, validate and publish compliant submissions based on CTD, eCTD, NeeS, IMPD, CTA, DMF, ASMF and other submission structure requirements.  The Docubridge system used by MMS meets requirements for eCTD and non-eCTD submissions, whether electronic or paper.  An integrated validation function also ensures compliance of the submission to ICH and regional specifications.

MMS has access to a full set of ICH CTD –compliant Microsoft Word templates covering all document types and a robust Style Guide, ensuring that documents are built with submission ready standards in mind from the beginning.

We also have access to both the FDA and EMA submission gateways and can submit on behalf of sponsors

Submission Processes

Our robust SOPs, work practices, submission ready standards, document and submission quality control checklists and access to industry leading eCTD validation software ensure that all electronic submissions we produce are technically valid and meet all agency requirements.

Are You Ready for the Upcoming eCTD Requirements in US and EU?

FDA and EMA are requiring eCTD submissions for many application types in the next year. See the table below for upcoming deadlines in the US and EU.   MMS can help you be ready to meet these requirements through our full set of electronic publishing and submission services.

Agency

Submission Type

eCTD Submission Required as of:

FDA

NDA

May 5, 2017

FDA

IND

May 5, 2018

FDA

DMF

May 5, 2018

EMA

New MAA using mutual recognition procedure

January 1, 2017

EMA

All regulatory activities in EU procedures (DCP/MRP)

January 1, 2018

EMA

New MAA in national procedure (NP)

July 1, 2018

EU

All regulatory activities in national procedures (NP)

January 1, 2019

Regulatory Submission Support Based on Strong Science and Strength of Process. We Do Data Best!

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