Strategic Document Planning
- We are experts in the requirements of all of the types of documents that are necessary for clinical development and registration.
- We can design and write documents that will meet the highest scientific, regulatory, and industry scrutiny.
- We will consult with you to determine your key messages and to ensure that these are conveyed accurately, consistently, and clearly across all of the documents in your clinical development and registration programs.
- We demonstrate an intense attention to detail with regard to scientific content, regulatory guidelines, specialized medical vocabulary, consistency in terminology and key concepts, and correct grammar and syntax.
Medical Writing Services
- Advisory Committee Brochures
- Responses to Regulatory Agencies
- Briefing Documents for Regulatory Agencies
- Safety Update Reports
- EU Marketing Authorization Applications (MAAs)
- US New Drug Applications (NDAs)
- Investigational New Drug (IND) Applications
- Investigator Brochures
- Patient Narrative Summaries
- Clinical Study Reports
- Crises associated with changing timelines and priorities
- Author relationships