Case Studies

Oral product for neonates and infants for a US based SME

Working as a "virtual" project team member in collaboration with the client and CRO, we provided support and advice on the selection of dosage form, excipients and primary packaging for an oral product to be administered to neonates and infants. Project activities also included the review of formulation and analytical experimental protocols, data and reports. We prepared the CMC sections of the IMPD for Phase 1 paediatric clinical studies, which led to successful approvals across the globe. This enabled the further optimisation of the product for Phase 2/3 and commercial.

Selection of vendor and design of pharmaceutical development studies in support of a PIP for European subsidiary of a global Japanese pharmaceutical company

We prepared pharmaceutical development experimental protocols to investigate the administration of a paediatric product via mixing with food/beverages and nasogastric feeding tubes, in response to questions raised by the EMA Paediatric Committee in response to a PIP application. We identified and assisted with the selection of vendors to conduct the work, monitored their progress, and updated the relevant regulatory documents, which led to approval of the PIP.

Selection of oral dosage form for infants and children for a US based SME

We conducted a review of potential age-appropriate oral dosage forms using a benefit risk approach on behalf of a client. This included an assessment of various criteria including the properties of the API, dosing requirements, compliance, safety aspects and supply. This enabled the client to make an informed decision regarding the formulation type to progress.

Management and delivery of a PIP for an EU FP7 funded research project

Worked collaboratively with the project consortium members to reach agreement on the paediatric development strategy, we prepared all the PIP documentation and were responsible for regulatory interactions and submissions, leading to successful approval of the PIP. We also successfully managed subsequent PIP modifications.