Medical Writing
Our medical writing team drives the process of document development,
and deeply understands the document subject matter.
medical writing has been expanded its roles from developing
study protocols to regulatory submissions assisted in
preparing documents in correct formats and standards.
Our medical writing team drives the process of document development, and
deeply understands the document subject matter. Furthermore, our strategic
medical writers work closely with the clinical team together with
comprehension of the process of drug development and regulatory strategy.
By adhering to ICH-GCP and KGCP guidelines as well as regulations of
Competent Authority, our medical writing professionals support and deliver
high-quality documents in a timely manner.
- Study document development and review
(IB, protocol, CRF, ICF, publications, abstracts) - Literature summaries of safety/efficacy
- Support for preliminary meetings with Regulatory Authorities
- CSR Writing
- Publication
- Literature Writing
- Investigator Meeting
