DUCK FLATS Pharma is comprised of professionals that have senior-level experience with a diverse knowledge of global regulations.
Our high-quality deliverables are focused on nonclinical development, pharmacokinetics, clinical pharmacology and translational medicine.
Combined, our team has managed over 400 regulatory documents and/or submissions. We have served as project leads for over 60 NDAs and more than 250 INDs. We have served as consultants on several Advisory Committee initiatives for the FDA and other global regulatory authorities.
Our group of experts can help you establish and implement a development plan, focusing on the mechanism of action, pharmacokinetics and pharmacodynamics of the drug or biotechnology compound being developed. The key focus is to determine the ideal translational medicine program that will ultimately support the approved indication in the targeted patient population.
DUCK FLATS Pharma provides our clients with a variety of PK + PD analyses to fit their needs. We can help design the right analyses to achieve your program goals.
Our List of Analyses include:
We can develop your strategies for targeted drug development plans specific to the therapeutic indication, and provide guidance for the right group of experiments for both in vitro and in vivo nonclinical programs (pharmacology, toxicology and nonclinical PK/metabolism/ADME). Our experts can assist with the determination of optimum bioanalytical development and assist with regulatory submissions (both domestic and international).
With our expertise, we can help you design: