We know how time consuming and complex it can be to file regulatory submissions across the globe. By partnering with Kendle, you'll have access to a global team of regulatory submission specialists each with local expertise in submitting applications in their region and extensive experience in filing submissions in a range of formats, including CDISC, ADaM and SDTM standards. They are experts in the development of Integrated Summaries of Safety and Efficacy (ISS/ISE) applications and have completed more than 25 ISS/ISE applications in the past few years.
Our flexible approach allows us to dedicate extra resources to your company when needed and for our biostatisticians to serve as your personal consultants, providing first-class strategic advice and innovative solutions to all of your regulatory issues.