Developing a strategic pediatric development plan applicable to multiple regions is a complex task, but fortunately is one at which Kendle excels. Our experts in local regulatory requirements are experienced in compiling plans from the intrauterine stage through to adolescents. We can help you to develop a globally-applicable plan that avoids the need for separate studies, saving your company time and a considerable amount of money.
On your behalf, Kendle can submit proposed pediatric written request documentation in the United States and requests to the EU’s pediatric committee in Europe. In addition, our extensive knowledge of the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act in the United States and Regulation (EC) No 1901/2006 as amended (the 'Paediatric Regulation') in the EU allows us to advise customers on the best approach.