Wordsmith medical writing

Careless writing makes people doubt the science behind it.

Wordsmith Medical Writing provides exceptional medical writing, editing, formatting, and publishing services for regulatory documents to sponsors and contract research organizations in the pharmaceutical and biotechnology industry. Our focus is on quality. Accuracy and presentation of regulatory documents is essential to clearly communicating your message. We’re here to help.
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Medical Writing

  • Preparation of clinical regulatory documents at the study level, across a development program, and for submissions
  • Regulatory health authority communications
  • Management of the document development process
  • Submission planning and oversight

Quality control and technical editing

  • Full and partial review of both clinical and non-clinical regulatory documents
  • Source verification for text and data
  • Inter- and intra-document consistency
  • Editorial review, style guide compliance, and alignment with templates

formatting

  • Application of formatting templates and styles
  • Alignment with specified formatting standards
  • Visual and technical inspection of content and attributes
  • Preparing for appropriate conversion to PDF

Publishing and regulatory operations

  • Document- and submission-level publishing of clinical and non-clinical regulatory documents
  • Alignment with eCTD-compliant standards
  • Ensuring appropriate conversion to PDF
  • Submission-readiness quality control review
  • Preparation and submission of eCTD-compliant dossiers

Consulting

  • Recommendations for and implementation of structures, standards, and processes
  • Training and instructional resources
  • Creation and/or maintenance of style guides, templates, standard operating procedures, checklists, etc.
  • Other projects as requested

Software Development

  • Creative technology solutions engineering
  • Development of custom software (e.g., formatting toolbars, template add-ins)
  • Creation of associated instructional documentation
  • Implementation planning and training

Behind The Business

Wordsmith Medical Writing was founded by Abigail Shetler, who is a board-certified Editor in the Life Sciences (ELS) and American Medical Writers Association (AMWA) member with extensive experience in global eCTD submissions; regulatory, medical writing, and quality control of regulatory documents; industry best practices; and technology and software.
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Education

Wordsmith Medical writing

Careless writing makes people doubt the science behind it.

Wordsmith Medical Writing is committed to providing high quality support and expertise to those who need a helping hand during the drug development process.
Let us help
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