Meet FDA and ICH expectations with ease
Whether you're preparing traditional toxicology studies or navigating high-stakes data issues, we help you meet FDA and ICH expectations while preserving momentum toward the clinic.
Our work spans radiopharmaceuticals, small molecules, antibody-drug conjugates, and animal rule studies, giving us the depth to tackle even the most complex study designs and regulatory challenges.
How we work
We understand that clients often need help navigating toxicology flags, selecting qualified CROs, or refining nonclinical strategy for FDA submission. Our team combines technical depth with regulatory fluency to create fit-for-purpose study plans, manage vendor execution, and support direct FDA interactions to de-risk your program and accelerate your path to clinical trials.
Our nonclinical engagements typically include:
Study design for
IND-enabling pharmacokinetic, toxicology, and safety studies
CRO selection, contract negotiation, and ongoing oversight
GLP audits and compliance support
Strategic nonclinical report review and regulatory engagement
Case Study
IND-enabling nonclinical program for a radiopharmaceutical
A biotech developing a novel radiolabeled antibody needed end-to-end support for its IND-enabling studies, which span biologic manufacturing, radioisotope handling, and GLP compliance.
Harmony designed the nonclinical strategy, coordinated across multiple vendors, and authored key IND sections covering pharmacokinetics, toxicology, and dose justification. We ensured study execution aligned with FDA expectations and addressed the unique regulatory challenges posed by radiopharmaceuticals.
IND
accepted without clinical hold
First-in-human trial launched on schedule
High-risk program advanced with regulatory confidence
Director of Preclinical Development
Radiopharmaceutical Company
"It was possible to allow Harmony to manage this portion of our development process where we don't have strong capabilities in-house. Harmony's knowledge of nonclinical regulations and GLP requirements made it possible to successfully receive approval for our Phase 1."
FAQ
Designing the right IND-enabling nonclinical program-particularly pharmacokinetic (PK), toxicology, and safety pharmacology studies-is critical to securing FDA acceptance and avoiding costly delays or repeat studies. Harmony combines deep regulatory expertise with hands-on development experience to design scientifically sound, phase-appropriate study packages aligned with FDA and ICH expectations.
We help you define the optimal scope, timing, and regulatory strategy for your nonclinical program, and we can support pre-IND engagement with the FDA to proactively validate your approach. Our goal is to de-risk your submission and position your program for successful entry into clinical development.
Unexpected findings in toxicology studies are not uncommon and, in many cases, can be effectively managed through robust scientific rationale and regulatory strategy. Harmony has deep experience navigating complex toxicology data challenges-including variability in study results, genetic toxicity concerns, and dose selection issues.
Our team combines technical expertise with regulatory insight to develop evidence-based justifications, propose mitigation strategies, and, when needed, engage directly with regulatory authorities. Whether you're preparing a response to FDA or adjusting your development plan, we help you protect timelines and preserve the viability of your IND or clinical program.
Selecting the right CRO is a strategic decision that should be guided by your product's modality, route of administration, regulatory requirements, and development timeline. A well-matched CRO partner can significantly impact data quality, regulatory acceptance, and program efficiency.
Harmony brings extensive experience working with top-tier nonclinical CROs across a range of therapeutic areas and technologies. We help you define your study needs, identify and evaluate qualified CROs, negotiate scientifically and commercially sound proposals, and conduct GLP compliance audits when needed.
Beyond selection, Harmony can oversee study execution to ensure quality data, proactive issue resolution, and timely delivery-establishing a high-performance CRO partnership aligned with your development goals.