Cedent Medical writers perform critical work that will allow our clients to take healthcare further, together. Our highly skilled consultants, will impact your strategies to develop regulatory pathways for your diverse product portfolio around the world..

• Briefing packages and supplements for investigational new drug (IND) and investigational device exemption (IDE) submissions
• New drug application (NDA) and premarket approval (PMA) submissions
• Creation of other regulatory submission documents (e.g., study protocols, clinical study reports, investigator brochures, BLA/MAA documents)
• Content and format, and also conforming to corporate standards and project- or therapeutic area-specific guidance
• Our consultants will follow appropriate company guidelines, procedures, SOPs, templates, and work instructions, consistent with relevant standards and applicable regulations and guidelines ‬
• Our consultants support non-regulatory writing projects such as manuscripts, abstracts, posters and specific research initiatives.