Core Content Network Llc

Core Content Network comprises a dedicated team of experienced writing professionals from the pharmaceutical industry. We enjoy helping companies meet their regulatory (ICH/FDA compliant) and technical writing needs. Our expertise includes the following services: Regulatory writing Technical writing Quality Control Review Project Management Format Capabilities Types of Regulatory Documents *Investigational New Drug Applications *New Drug Applications *Abbreviated New Drug Applications *Biologics License Applications including biosimilars *Regulatory Submissions for European and Canadian agencies *Clinical Study Reports (Phase 1 to 4)*Clinical Study Protocols (Phase 1 to 4)*Investigator's Brochures *Safety Narratives *Safety Reports (Development Safety Update Reports, Risk Management Plans, 120-Day Safety Updates)*Integrated Summaries of Safety/Efficacy *Briefing Packages *Regulatory Responses *Qualified Infectious Disease Product Medical Affairs Manuscripts Abstracts Posters Therapeutic Areas Anesthesia Autoimmune diseases Biologic and biosimilar agents Cardiology Dermatology Infectious diseases (including COVID-19) Metabolic diseases Neurology Oncology Pain, chronic and acute Rare diseases Renal diseases Respiratory Transplantation Let us help you meet your writing goals! Email: srogers@corecontentnetwork.com