At Kendle, we understand the importance of high-quality regulatory submissions and can offer the global reach and unrivalled experience to help our customers’ meet their goals. Our Regulatory Affairs associates are located around the globe and have detailed knowledge of the different local submission processes, administrative requirements and agency-specific ways of working, combined with the expertise to complete submissions in most major markets. In line with the growing need for simultaneous global submissions, we work to ensure a drug’s final licenses around the world differ minimally in therapeutic indication, patient population and manufacturing requirements without compromising flexibility upon approval.
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