Core Content Network LLC

Core Content Network LLC is a women-owned medical writing consultancy founded in 2020 by Dr. Sharon Rogers, PhD, ELS. The company specializes in regulatory medical writing for pharmaceutical and biotechnology companies, with particular expertise in FDA submissions including INDs, NDAs, BLAs, and biosimilar applications.

The firm provides comprehensive regulatory documentation services spanning clinical, nonclinical, and CMC writing, as well as safety reports, protocols, clinical study reports, and integrated summaries. Core Content Network also offers quality control, eCTD formatting, document assembly, and project management services to support clients through the entire submission process. The team consists of experienced scientists and consultants with expertise in analyzing complex clinical data and meeting regulatory requirements.

Dr. Rogers brings over 25 years of medical writing experience, including tenure at large pharmaceutical companies, boutique medical writing firms, and clinical research organizations. She has been a member of the American Medical Writers Association since 2008 and an Editor of Life Sciences since 2009.

Organizations should consider Core Content Network when they need specialized regulatory medical writing expertise without maintaining full-time writing staff. The firm excels in managing tight timelines and complex regulatory submissions, particularly for companies navigating their first FDA submissions or requiring temporary writing support during critical submission periods.

Clients can expect hands-on project management, quality-controlled documentation that meets regulatory standards, and support from writers with direct pharmaceutical industry experience. The focused service model allows for flexibility in engagement scope while maintaining quality standards appropriate for regulatory review.

Core Content Network operates exclusively in the pharmaceutical and biotechnology healthcare sector, focusing on regulatory submissions to the FDA and other regulatory agencies. The firm specializes in drug development documentation across all phases of clinical trials, from early-stage IND applications through NDA and BLA submissions, including specialized pathways like ANDAs, 505(b)(2) applications, and biosimilars.

The company's healthcare expertise extends to safety documentation including DSURs, Risk Management Plans, and safety narratives, as well as specialized designations such as orphan drug designations (ODDs) and qualified infectious disease products (QIDPs). This regulatory focus positions the firm to serve the specific compliance and documentation needs of pharmaceutical product development.

The ideal client is a pharmaceutical, biotechnology, or medical device company preparing for FDA regulatory submissions that requires experienced medical writing support. This includes small to mid-sized companies without dedicated regulatory writing teams, virtual biotech firms, and larger organizations needing temporary capacity during submission periods or for specialized therapeutic areas.