Regulatory Writing for IND, NDA, and CTD Submissions
Authoring clear, precise regulatory modules for CTDs, INDs, and NDAs that communicate complex bioanalytical and pharmacokinetic science with confidence and meet global regulatory standards.
Expert Regulatory Writing for Every Stage of Development
Pharmacokinetics, Bioanalysis, and ADME science written right—at every stage. Successful submissions depend on regulatory documents that are both scientifically accurate, strategically written, and answer the question: “What is the narrative you are trying to communicate?”
Well-prepared documents that clearly articulate complex scientific data can reduce delays and confusion with the regulatory authorities, facilitate productive agency interactions, and build confidence in you and your program. When it comes to regulatory writing, you need a team with decades of hands-on drug development experience, transforming complex pharmacology, bioanalytical, in vitro ADME, toxicokinetics, and clinical pharmacology data into clear, compliant documents with accurate messaging.
Xyzagen’s Approach to Regulatory Writing
As a boutique consultancy, our clients work directly with the senior scientists authoring their regulatory documents. Our experts ensure every submission is scientifically rigorous, strategic, and aligned with agency expectations. Being boutique also means we deliver faster—providing submission-ready documents more quickly than larger firms—so you can move efficiently through regulatory milestones, from discovery to NDA. Whether you need to accelerate your IND or NDA, we help you get there with confidence.
Acting as an extension of your team, we ensure protocols, study reports, and submission packages communicate value with precision. By incorporating Model-Informed Drug Development (MIDD) strategies, we also strengthen Phase 2 and 3 clinical trial design, dose selection, and overall regulatory strategy, in addition to your submission documents.
Protocol Development
Developing clear and compliant protocols is critical to generating reliable nonclinical and clinical data. All protocols have a thought towards MIDD strategies to optimize dosing, study design, and regulatory readiness, particularly when you advance to your population PK analysis. Xyzagen supports protocol writing and review for:
Nonclinical studies
Pharmacokinetics (PK), toxicology (for toxicokinetic endpoints), and in vitro ADME and nonclinical pharmacology
Clinical pharmacology studies
First-in-Human (FIH), bioavailability/bioequivalence (BA/BE), and drug-drug interaction (DDI) studies
Phase 1–3 clinical trials
Including study design, PK/PD sampling strategies for population PK, and data collection plans
Common Technical Document (CTD) Writing
The CTD is the standard format for IND, NDA, and global submissions. Our writing ensures scientific clarity, regulatory compliance, and a structured presentation of nonclinical and clinical findings. Xyzagen provides comprehensive writing for:
Module 2: Nonclinical Overview (2.4), Nonclinical Summaries(2.6), Clinical Overview (2.5), Biopharmaceutics (2.7.1) and Clinical Pharmacology (2.7.2)
Investigational New Drug (IND) Writing
Xyzagen supports your robust IND submissions in collaboration with your regulatory group as a Subject Matter Expert (SME) in Pharmacology, Bioanalysis, and Pharmacokinetics (PK) and can support the allometric scaling that justifies the initiation of human trials at the most appropriate dose based on pharmacology, PK, and regulatory guidance. We ensure all required studies are in place and presented clearly, reducing regulatory delays and accelerating approval readiness. Our team supports:
New Drug Application (NDA) Writing
By combining regulatory expertise with scientific insight, we help clients navigate complex submissions and improve the likelihood of regulatory success. For NDA and Biologics License Applications (BLA), Xyzagen develops integrated regulatory documentation, including:
Why Choose Xyzagen?
With decades of experience in regulatory writing and submissions, our senior scientists bring both technical depth and practical insight. We integrate closely with client teams, anticipating challenges and translating complex data into clear regulatory narratives. Our team has extensive experience interacting with global authorities, including the FDA, EMA, Health Canada, MHRA, and the Australian TGA, helping your submissions meet international standards and progress smoothly toward approval.
Partner with Xyzagen
Contact us today to learn how our Clinical Pharmacology Gap Analysis can streamline your development program, reduce regulatory risk, and guide efficient decision-making.
