Paidion Research Durham NC

Regulatory
In the world of drug development, timing is everything. We can help.

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's deep experience in dual submissions works for our sponsors: we've successfully reduced the number of required trials and significantly tightened/streamlined the approval time line, 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. Our pharmacometric expertise provides unparalleled support for regulatory filings and product labeling in pediatric patients. 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.

Seasoned i-dotters and t-crossers, Paidion Research's regulatory affairs experts will help you navigate demanding regulations and guidelines, whether for initial submissions or throughout trial execution.

Services

  • Regulatory Consulting
  • Regulatory Agency Liaison (FDA, EMA, PDCO, etc.)
  • Pediatric Study Plan Development and Submission
  • Pediatric Investigation Plan Development and Submission
  • Medical Writing