Gaining approval for a new medicine for use in a paediatric environment is a challenging endeavor: How to conduct the right paediatric trials, labelling, dosage, managing the ethical landscape, as well the stringent regulatory landscape, coupled with balancing the cost effectiveness of such programmes. Ensuring you have an effective paediatric plan (or waiver) in place is crucial to allowing an MAA to be submitted in Europe and increases the chance of establishing a robust, feasible clinical plan and obtaining a paediatric indication.
The NDA Paediatrics Team comprise regulatory consultants experienced in industry and regulatory authorities, trained in the latest requirements to facilitate a successful and efficient paediatric development strategy and PIP application. With NDA, you gain first-hand experience on every step of developing a PIP, the obstacles and hurdles to be addressed, coupled with in depth knowledge of the regulatory procedures, and the key stakeholders and therapeutic areas via our network of experts.
Our track record
NDA has managed the successful delivery of more than 30 PIP Applications. In addition we have provided strategic advice to over 40 PIP projects including selection of the relevant paediatric condition, convening advisory boards with leading KOLs to develop study designs. We routinely advise on PIP modifications, deferral and waiver strategies, compliance checks and EU and US paediatric plan alignment. Our track record is established with successful ‘right first time’ outcomes and timely approvals.
How we help
NDA has thorough understanding of paediatric drug development and how it sits within the overall product development is married with a deep knowledge of regulatory requirements, including the interplay with orphan drug legislation, to facilitate a successful and efficient paediatric development strategy and PIP application. We can guide you through the complete process, from age-appropriate formulations, non-clinical study requirements, and clinical study designs to PIP approval and maintenance. We are also experienced in the content and submission process for FDA Pediatric Study Plans (PSPs) and Written Requests.