Whitsell Innovations, Inc.

Whitsell Innovations (WI) is a medical and scientific writing company founded in 2006, specializing in regulatory documentation, quality control, and eCTD publishing for pharmaceutical, biotech, and medical device clients. The Chapel Hill, North Carolina-based firm operates as a fully remote organization with employees across 27 states.

The company provides regulatory writing services including protocols, investigator's brochures, clinical study reports, and full submissions (INDs, NDAs, 510(k)s, PMAs). Their capabilities extend to medical communications, quality control review, and eCTD publishing services added in 2019. WI staff members hold scientific backgrounds with most having advanced degrees and experience in GLP, GMP, and GCP documentation standards.

In 2021, WI invested in developing proprietary tech-enablement tools to enhance quality and efficiency, earning recognition as the DA4S '8 That Innovate' runner-up in 2022. The company operates as a WBENC-certified woman-owned small business with a stated commitment to environmental, social, and corporate governance principles.

Organizations should consider Whitsell Innovations when they require regulatory writing expertise combined with personalized service and direct team engagement. The firm's specialized focus on regulatory submissions, combined with their quality control and eCTD publishing capabilities, provides an integrated workflow for companies navigating FDA and international regulatory requirements.

Clients can expect engagement with scientifically trained writers who understand complex clinical and nonclinical data. The boutique model emphasizes individualized attention and senior-level involvement, which may appeal to organizations dissatisfied with larger outsourcing firms.

Whitsell Innovations exclusively serves the life sciences healthcare sector, focusing on pharmaceutical, biotech, and medical device clients navigating regulatory approval processes. Their writers specialize in therapeutic areas including oncology, infectious disease, cardiovascular diseases, diabetes and metabolic diseases, ophthalmology, hepatology, and respiratory conditions.

The team's expertise in Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP) documentation standards positions them to support clients through IND, NDA, 505(b)(2), 510(k), and PMA submissions to the FDA and international regulatory authorities.

The ideal client is a pharmaceutical, biotech, or medical device company requiring regulatory documentation support for FDA submissions or international regulatory filings. Organizations valuing direct access to scientifically trained writers and senior staff throughout projects, rather than working through account management layers, will find the boutique model advantageous.