Confidence Beyond Compliance
Children deserve medicines adapted to their needs. Although these needs are nowadays routinely addressed in new drug developments, global development programs in pediatrics still remain a challenge.
In-depth understanding of the US and EU pediatric regulatory systems and the FDA/EMA pediatric cluster collaboration is key to agree on a harmonized pediatric development approach. This will expedite your pediatric development and avoid that children are unnecessarily exposed to risks by eliminating duplicate clinical trials.
- Strategic consultancy to project teams on scientific and regulatory aspects of pediatric development targeting alignment between EU and US programs
- Reviewing of EU and US pediatric plans (PIP, PSP) including waivers and deferrals
- Regulatory writing of EU and US pediatric plans, waivers, and deferrals
- Guidance and operational support for EU and US pediatric plan application procedures (e.g. separate PSP and PIP applications, alignment by interaction with FDA / EMA pediatric cluster)
- Scientific and regulatory guidance to project teams on implementing and maintaining compliance with approved pediatric plans
- Preparing and managing health agency meetings (e.g. meeting strategy, rehearsals, contribution in meeting and follow-up, writing of briefing material and company-internal minutes)
- Review of clinical trial designs, protocols, and study reports with respect to the defined pediatric strategy as well as related documents for clinical trial applications (EU / US)