Regulatory Interaction Support
Every regulatory interaction is an opportunity to strengthen your program’s path to approval. We build regulatory confidence by ensuring your Nonclinical ADME and Clinical Pharmacology summaries are aligned with your overall goals.
Confidently Engage with Global Regulatory Agencies
Preparing for a successful pre-IND meeting, End-of-Phase 2 (EOP2) discussion, or NDA/BLA submission depends on a clear understanding of your core foundation—what the body is doing to the drug, or pharmacokinetics (PK). A clinical and medical strategy is strongest when both pharmacology and PK are well understood, and your team can communicate the science effectively.
Building on a Strong Scientific Foundation
A house can’t stand without a good foundation. Regulatory meetings are critical milestones in drug development, shaping the trajectory of your program and informing future studies. Thus, it’s important to ensure you are building from a solid foundation, which starts with your bioanalytical methods. Whether you are developing methods for small molecules, metabolites of small molecules, large molecules, or ADA methods for large molecules, beginning with a strong bioanalytical and in vitro strategy supports the rest of your nonclinical ADME, TK, and clinical pharmacology approaches to product development.
Xyzagen’s Approach to Regulatory Interaction
At Xyzagen, we partner with small to mid-sized biotech companies who need complementary expertise or direct access to regulatory submission and meeting specialists, particularly in the area of bioanalysis and pharmacokinetics. Our team ensures you approach each interaction prepared, confident, and strategically aligned with agency expectations.
As a boutique consultancy, we adapt to the level of support you need—acting as a seamless extension of your team or providing targeted expertise. Our senior level scientists are regulatory strategists and subject matter experts, having accrued decades of hands-on experience guiding drug development programs from discovery through NDA submission.
Xyzagen’s Regulatory Interaction Services
Mock Meetings and Preparation:
to ensure your team is confident, aligned, and ready to address agency feedback
Strategic Input on Questions and Briefing Documents: to highlight your program’s value and anticipate regulatory concerns
End-to-end Guidance: across key regulatory milestones, including Pre-IND, EOP2, and NDA/BLA meetings
Advisory Committee Support: from slide presentation and mock committee interactions within nonclinical ADME/PK and Clinical Pharmacology
Why Xyzagen?
Unlike large CROs, Xyzagen gives you direct access to senior scientists who have taken programs from bench to bedside. We not only prepare your team for agency interactions—we can also attend and actively represent your program during regulatory meetings.
This ensures your science is communicated with precision and authority. With our boutique structure, you get faster preparation, deeper scientific insight, and submission-ready materials that align with regulatory expectations—helping you hit milestones on time and with confidence.
Partner with Xyzagen
Every regulatory interaction is an opportunity to strengthen your program’s path to approval. Partner with Xyzagen to prepare strategically, communicate effectively, and move your development forward.
