|
Kendle's Regulatory Affairs team understands the importance of the highest quality regulatory submissions. We’ll work with you to plan, prepare and complete global or local submissions and will communicate, interact and liaise with regulatory agencies to ensure approval on time.
First-class regulatory submissions require the highest quality medical writing. Kendle medical writing and regulatory teams produce reports and submissions that meet the standards of the most exacting regulatory agencies in the world.
Our interactive approach ensures we understand your requirements early in the report writing and regulatory submissions process.
Kendle's regulatory submission and medical writing services
- Protocol writing
- Technical writing for chemistry and manufacturing, non-clinical, and clinical reports and publications
- Chemistry and Manufacturing, Non-clinical and Clinical Expert overviews, reports and reviews
- Regulatory Intelligence: Rockville, US Ely, UK
- Technical writing and assembly of clinical trial and marketing authorization applications for new chemical entities, biologics, generics and medical devices
- Dossier conversion from NDA, old European format and others to CTD and eCTD [Ely, UK ]
- Orphan drug designation applications
- Dossier maintenance, including annual reports, license variations and renewals
- Change of legal status (POM to P switch) applications in the UK
- Safety surveillance and pharmacovigilance reporting (PSURs)
|
