An integral part of the drug approval and submission process is to create well-written and well-structured documents that comply with applicable regulations and authorities. Regulatory medical writing is a highly specialized field that involves bringing together information from clinical trials, safety reports and other key documentation, with the goal of producing submission ready documents for the targeted audience.
Celegence’s global medical writing specialists are experts in the drug development process, multiple therapeutic areas and product types, with in-depth knowledge of regulatory, clinical, and scientific contents perfectly integrated with technical, editorial and quality control capabilities. Our medical writers are well versed in working with various stakeholders such as clinical operations, data management, biostatistics, medical and safety teams. Our team also has broad industry experience, drawn from pharmaceutical and medical devices companies, CROs and service providers, and academia with extensive experience in all forms of medical and scientific writing, including regulatory, clinical, safety, and publication documents.