Wordsmith Medical Writing LLC

Wordsmith Medical Writing LLC is a specialized regulatory medical writing firm founded in 2019 by Abigail Shetler, a board-certified Editor in the Life Sciences. The company provides medical writing, editing, formatting, and publishing services for regulatory documents to pharmaceutical and biotechnology sponsors and contract research organizations globally.

The firm offers comprehensive support across the drug development lifecycle, from individual study-level documents to complete eCTD submissions. Core capabilities include preparation of clinical study reports, protocols, investigator's brochures, Development Safety Update Reports, Module 2 summaries, and regulatory authority communications. The team also provides quality control services, document formatting, submission-level publishing, and custom software development for regulatory operations.

The company has supported clients ranging from emerging biotechnology companies to established pharmaceutical organizations including Takeda, Immunovant, and Recursion Pharmaceuticals. Wordsmith has developed training partnerships with Ideagen and PleaseReview, and has helped establish medical writing departments for several pharmaceutical and biotechnology companies.

Choose Wordsmith Medical Writing when you need specialized regulatory documentation expertise backed by board-certified editors and medical professionals. The firm excels in situations requiring meticulous attention to eCTD compliance, source verification, and regulatory formatting standards. Their experience establishing medical writing functions makes them particularly valuable for companies building or optimizing their regulatory documentation infrastructure.

Expect a quality-focused approach with detailed document review, technical editing, and submission-readiness verification. The combination of medical writing, publishing operations, and custom software development provides integrated solutions for companies seeking to streamline their regulatory documentation workflows.

Wordsmith Medical Writing operates exclusively within the pharmaceutical and biotechnology sectors of healthcare, focusing specifically on regulatory documentation for drug development. The team's expertise centers on clinical trial documentation including protocols, clinical study reports, investigator's brochures, and patient safety narratives required for regulatory submissions to health authorities.

The company maintains Good Clinical Practice (GCP) certification and understands regulatory requirements across global markets. Their work directly supports the drug approval process, requiring detailed knowledge of ICH guidelines, eCTD technical specifications, and health authority expectations for clinical documentation quality and completeness.

The ideal client is a pharmaceutical or biotechnology company with active clinical development programs requiring regulatory documentation for FDA or international health authority submissions. This includes sponsors preparing INDs, NDAs, or BLAs, as well as CROs supporting multiple clients with regulatory writing and publishing needs. Companies establishing or optimizing their medical writing departments will particularly benefit from Wordsmith's consulting and training expertise.