Regulatory & Medical Writing

Fueling the Future of Radiopharmaceuticals

Cadena Research has full medical writing services to support regulatory submissions and scientific communication needs across the drug development lifecycle.

Regulatory medical writing focuses on producing highly technical documents that comply with strict standards such as ICH guidelines. These include:

Investigational New Drug (IND) application
Clinical Trial Application (CTA)
New Drug Application (NDA)
Drug Master File (eDMF)
Orphan drug and device designation
Fast track designations
Clinical Study Protocols
Clinical Study Reports (CSRs)
Investigator’s Brochures (IBs)
Common Technical Documents (CTDs) for submission to regulatory authorities (e.g. FDA, EMA)
Informed Consent Forms (ICFs)

Medical communications and publications writing is aimed at disseminating scientific findings to healthcare professionals and the public. Deliverables in this category include:

Manuscripts for journals
Conference abstracts and posters
Educational slide decks
Patient education materials