Emily Stephens

Background

About Emily Stephens

Global Regulatory Writing & Consulting specializes in general clinical, strategic regulatory, nonclinical, and CMC/manufacturing submissions across medical device, biologics, biosimilars, and drug development. My company works in teams that are carefully assembled in order to provide the best support in the following areas of documentation: 1. Cell Therapy, CAR T-cell Therapy, Immunotherapy, and Oncolytic Virus and Vaccines: Cradle to grave eCTD writing support for CMC, clinical, and nonclinical writing from the IND to the BLA to the Annual Reports and Post-market Studies 2. Clinical Safety Data: DSUR, PSUR, and Patient Narratives 3. Medical Device: MEDDEV 2.7/1 Rev 4-compliant CER/CEP and Chinese CER, 510k, CE Application, Safety & Risk Analysis, Risk Management Report, and Safety Risk Management Procedure Policy research and documentation, MDR-preparedness Gap Assessment, development of PMS and PMCF Plans, literature reviews and analyses for Safety & Performance Claims, Marketing and R&D, white papers 4. General Clinical: Protocol, Investigator Brochure, Clinical Study Report, Informed Consent Form, Investigative New Drug, Biologics License Application, New Drug Application, Marketing Authorisation Application, Pediatric Study Plan/Paediatric Investigation Plan 5. Strategic Regulatory Writing: Pre-Pre- and Pre-IND Briefing Documents, FDA/EMA/Health Canada/PMDA/CFDA Responses and Meeting Request Briefing Books, accelerated approval such as Fast Track, Orphan Drug, and Breakthrough Therapy Designation Applications Our detailed knowledge of the requirements for preparation of INDs and BLAs make eCTD-compliant submissions a smooth ride. Consider us interested in anything ground-breaking!