Medical Writing

• High quality data presentation & writing in accordance with global regulatory standards with sophisticated planning and execution
• Experienced-based study protocol & ICF development
• Integrated study report writing in eCTD format with hyperlinking & bookmarking
• Preparation of FDA Summary Tables for ANDA Submissions
• Custom format reports
• CD-ROM copy and hard copy of reports and associated study data
• CS-BE preparation for TPD submissions
• Compilations of abstracts, manuscripts, publications & poster presentations

The integrated study report is the final deliverable that LTRI provides its clients, so that our goal is to issue this report in the shortest time possible.

Our standard reports are prepared to conform to the requirements of the ICH E3 “Structure and Content of Clinical Study Reports”. Past experience and regulatory expertise ensures that reports are written to minimize any possible delay in regulatory approvals.