Regulatory writing

A reader chooses here by the kind of regulated product the work is for, once it is settled which framework the product falls under: first the classification of a product on the border between frameworks, then a medicine, a medical device, or another regulated product such as a cosmetic, a chemical or a pesticide. Veterinary medicines are left to veterinary medical writing, the science of how a medicine is developed to developing a medicine, the consent materials and lay summaries a trial gives its participants to documents for patients and trial participants, and the case for a product's value to payers to market access and health technology assessment.

• Borderline products and regulatory classification — settling which regulatory framework a product falls under, before there is any template, evidence package or agency to write to
• Medicines — the regulatory framework, clinical trials, marketing authorisation, safety and pharmacovigilance, transparency and disclosure, and managing regulatory documents
• Medical devices — device regulation and market access, clinical investigations, clinical evaluation, post-market surveillance, and devices with requirements of their own
• Other regulated products — the cosmetic product information file, and chemical and pesticide dossiers