MLR Submission Content: Setting Yourself up for a Successful PRC Review

June 24, 2024

Having a highly efficient well-oiled Promotional Review Committee (PRC) machine is not just about having rock star reviewers and effective best practices in place. Although those are both critical components of a successful PRC, creating an efficient PRC actually begins prior to these aspects. The first step in the entire process is the Medical, Legal, and Regulatory (MLR) submission content.

This highly underrated but crucial step is key to setting up your PRC to be as efficient and effective as possible.

Just like any process, how you start directly impacts how you finish.

Let’s take a deeper dive into what makes a best-in-class MLR submission for PRC.

Efficient PRCs Are Built on Well-Prepared MLR Submissions

PRCs are the gatekeepers of advertising and promotional review, the trifecta that is needed to ensure high quality, compliant, and ultimately commercially successful advertising and promotional materials.

Before the trifecta begins to work its magic, there’s a crucial, and sometimes highly underrated, step that needs to occur: material preparation. This preparation directly impacts the speed and efficiency of the review.

Providing a well-prepared, high-quality MLR submission package and using appropriate review systems directly relates to the efficiency and effectiveness of the reviews.

Conversely, having incomplete, sloppy materials or inefficient systems to support the MLR review only slows down the PRC process, creating unnecessary delays due to multiple rounds of reviews and material revisions.

MLR Submission Checklist

How do you create a best-in-class submission package that provides your reviewers with clean and easy to review materials? An MLR review checklist. Why a checklist? To ensure key components of a best-in-class MRL submission package are included.

Timing and Scheduling

  • Create and clearly communicate timelines to the team, including the MLR reviewers. Understanding when a piece is needed impacts the timeline for both the submission and review deadlines.
  • If possible, set up automated reminders for the reviewers. This will help them keep track of what reviews are coming up and the review deadlines.
  • Establish standard and expedited review times. The norm is typically five days for standard reviews and two days for expedited reviews.
  • Ensure the review meeting allows for enough time for each piece to be discussed as needed. Adjust timing as appropriate.

Roles and Responsibilities

  • When assembling your team, make certain that every person needed to review content is included. Normally an MLR review team is comprised of five to seven reviewers and sometimes an additional one or two observers.
    • Observers are typically interested stakeholders who can view the materials and add and reply to comments; however, their approval is not required. These can be company project managers/coordinators and/or agencies responsible for updating material content as appropriate and necessary.
  • Ensure that the entire team is aware of everyone’s roles and responsibilities. This enables the team to efficiently and effectively communicate with the correct people regarding any questions and/or comments.
  • Identify and communicate the content owner to the team. The content owner is sometimes referred to as the project manager, author, submitter, or lead. Knowing who this person is allows the team’s feedback to be provided in a more direct and efficient manner.
  • Direct reviewers to be as specific as possible with their comments and, if applicable, identify the person the comments are directed at. Using a system where reviewers can tag or mention a person can greatly decrease review time and cut down on discussions during live reviews.

Use of Systems for Reviews

  • Utilizing an electronic system for capturing and resolving comments, discussions, and questions creates an audit trail and a source of truth for the material reviews.
  • Have a system that supports the various file formats that materials will be provided in (PDFs, Power Point, videos, etc.)

Materials and Material Preparation

  • Ensure you have provided the review team with the most current version of the materials and that any/all related or supporting materials (previous versions with comments, referenced documents, translations, etc.) are easily accessible as attached files.
  • As applicable, export PDF file(s) to include hyperlinks.
  • Convert all non-PDF files (e.g., PowerPoint, Word documents) to PDFs for submission.
  • Ensure all reference materials related to the materials being reviewed are available to the reviewers.
  • Provide all applicable references as needed with materials being routed for review.
  • Annotate and tag files and materials to include sources to all claims.
  • Create tags for pieces indicating brand/project, type of content (scientific paper, press release, email, detailed aid, social media, website, etc. If using an electronic system to route materials, ensure this type of information is added to the metadata.
  • Assign a unique ID code for each material. If using an electronic system to route materials, this will be added automatically.
  • When submitting documents for review and approval, ensure the appropriate tags and annotations for references are provided within each piece.
  • For all web/app content, materials must include navigation structure and screenshots of all states. Also provide the reviewers with applicable draft/staging site(s) for verification of interactivity and functionality.
  • For videos, ensure transcripts are provided as attachments for reviewers’ reference.

Having a best-in-class MLR submission package is ultimately about helping your reviewers be as efficient and effective as possible. Providing your MLR team with high quality, compliant materials the first time allows reviewers to focus on the review itself rather than having to deal with issues around inadequate and unreviewable materials. Using tools like an MLR review checklist ensures you are setting up your review team for success from the start.

ProPharma: Expert MLR Submission Consultants

The PRC is the gatekeeper, the trifecta of Medical, Legal, and Regulatory reviewers helping you get the highest quality advertising and promotional pieces possible. Before the MLR team can complete their reviews, some behind the scenes magic needs to occur. The “magic” is your best-in-class MLR submission for PRC.

Everything from material prep, technology used, SOPs, and governess of the MLR submission process ensure you are creating a best-in-class MLR submission package for your team to review.

Wherever you are in the continuum of the ad prom process – just beginning and don’t know where to start, need to revitalize your advertising and promotional process, or are looking for expert PRC review consultants, ProPharma’s Regulatory Sciences team can help. 

The World's Leading Regulatory Consultancy

Our expert advertising and promotional review consultants have extensive experience in the industry and are prepared to assist you throughout the entire process. Contact us today to learn how we can help with any and all of your regulatory affairs consulting needs.



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