How We Help

Our highly trained Editors understand the unique needs of material creation and review within Life Sciences. We partner with stakeholders throughout the process to ensure materials are created, approved, and released for use in accordance with corporate and brand guidelines, and are compliant with FDA regulations.

Joanna Bova, PMP - Executive Director, Process Management

Joanna Bova, PMP
EVP, MLR Solutions

We work in tandem with clients to develop quality guidelines for submissions, ensuring material submitted for review meet review-readiness thresholds. Our post-review editorial services include thorough “check changes”, ensuring all committee-directed edits have been incorporated and no non-committee directed changes have been made.

Our regulatory editorial services integrate into our clients’ pre-submission, regulatory operations processes, ensuring production proofs and submission files match final committee-approved materials. Our editorial services extend post digital deployment. Working with agencies and media planning, our Editors review in-market digital materials, including websites and banner ads, to ensure public facing materials are fully functional and mirror the final approved materials.

Our Editors are well versed in FDA regulations, SOP adherence, and industry editorial standards; and help ensure quality, accuracy, and compliance.

Our editorial team successfully augments your Promotional and Medical Review Process; working with stakeholders to ensure final materials reflect brand guidelines and stakeholder direction. We focus on the operational tasks, allowing you to focus on the creative initiatives.
Services Include:
  • Quality Pre-Review, Assess Readiness

  • Proofread documents (Check Changes)

  • Proof eCTD Files for Accuracy

  • Proof in-Market Assets to ensure Compliance

  • Deployed Asset Monitoring

  • Regulatory review of production proofs and submission packages

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Transformation through Collaboration