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!
https://www.corecontentnetwork.com/
Email: srogers@corecontentnetwork.com

Core Content Network LLC

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