Address the Unmet Needs in Paediatric Drug Development with Lambda
06 Apr 2023
Address the Unmet Needs in Paediatric Drug Development with Lambda
Partner with Lambda for customized solutions at a project, program and compound level in paediatric drug development.
The Lambda Advantage
- An experienced and proficient team of experts
- Successful Navigation of complex regulatory pathways and requirements
- Regulatory writing, publishing and submission support for PIP and PSP
- Preparation of PIP, PIP waiver, deferral, PUMA, PDCO submission to, modification of PIP, compliance check
- Briefing Documents for regulatory authority meetings / scientific advice
- Strategic Planning of paediatric study plans (PSPs), paediatric investigation plans (PIPs) and Paediatric clinical trial study design
- Data-driven Insights to enhance trial design, site identification, recruitment and endpoint development
- Modelling and simulation, characterizing PK, PD, disease progression, safety and efficacy