Advance your pediatric program with specialized regulatory expertise
In today’s competitive drug development arena, a well-planned strategy to support individual or dual submission to FDA and EMA is critical to success. Paidion, in partnership with Camargo Pharmaceutical Services, delivers deep experience in dual submissions works for our sponsors: We’ve successfully reduced the number of required trials and significantly tightened/streamlined the approval timeline, with the ultimate outcome of decreased overall costs. We are practiced strategists with expertise in development and submission of PIPs and PSPs, with an excellent track record of collaboration with sponsors to support these plans with regulators.
Our capabilities span the gamut from strategic development to medical writing and protocol design, including submission of deferrals, waivers and modifications to initial plans. Through a strategic combination of in-house proficiency and global collaboration, we can provide you with a uniquely qualified team ready to serve as your virtual regulatory department or to complement your internal group.
- Regulatory Consulting
- Regulatory Agency Liaison (FDA, EMA, PDCO, etc.)
- Pediatric Study Plan Development and Submission
- Pediatric Investigation Plan Development and Submission
- Medical Writing