Paediatric Investigation Plans (PIPs) and Paediatric Use Marketing Authorizations (PUMAs):
Paediatric Strategy Development:
Tailored PIP Strategies:
We collaborate with you to create customised Paediatric Investigation Plans (PIPs) that align with your product’s development goals and when needed the specific paediatric populations it targets.
ERA helps you design paediatric studies that are scientifically sound and compliant with regulatory requirements.
Our experts guide you through the process of preparing and submitting Paediatric Use Marketing Authorization (PUMA) applications when applicable.
ERA ensures that your PUMA applications include comprehensive paediatric data and meet the regulatory criteria for paediatric indications.
Study Design and Conduct:
Paediatric Study Support:
ERA assists in designing and conducting paediatric clinical trials, ensuring that they are ethically conducted and meet the highest scientific standards.
We help you navigate the complexities of paediatric research, including obtaining informed consent from parents or guardians.
Data Analysis and Reporting:
Our team supports you in analysing paediatric study data and preparing regulatory submissions. ERA ensures that your paediatric data is presented accurately and comprehensively.
Regulatory Authority Liaison:
We serve as your liaison with regulatory authorities, facilitating communication and interactions related to paediatric submissions.
ERA helps address regulatory queries and ensures timely responses.
If granted a PUMA, we assist in the maintenance and post-approval obligations, including annual updates on paediatric studies and compliance with PUMA conditions.
ERA helps ensure the ongoing validity of your PUMA.
By partnering with ERA for PIPs and PUMAs, you gain a trusted advisor dedicated to addressing the unique regulatory challenges and opportunities related to paediatric populations. Our commitment to strategic planning, study design, regulatory compliance, and ethical research ensures that your products meet paediatric requirements and gain access to this important patient population.