Template Development 

Template development and expert-lens editing to meet regulatory requirements 

Our medical writing experts can help you tailor a complete range of regulatory documents that safeguard the compliance and quality of your vital writing outputs. We develop streamlined templates that enable your writers to cut back on time spent setting up each document and inversely allocate it developing relevant content. We also systematically design or re-edit template documents to ensure consistency in structure and appearance between similar documents authored by different writers. All professionally developed templates by Aolete experts are quality assured blueprints that contain the information regulatory agencies need, in the most up-to-date formats they prefer. 

The templates our regulatory expert teams develop, edit, and amend for ensured regulatory compliance and efficiency include: 

• Clinical Evaluation Plan (CEP)

• Clinical Evaluation Report (CER)

• Post Market Surveillance Plan (PMSP)

• Post Market Surveillance Reports (PMSR)

• Periodic Safety and Update Reports (PSUR)

• Summary of Safety and Clinical Performance (SSCP)