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Nonclinical Efficacy Testing » The drug development process, and where nonclinical work sits in it

The drug development process, and where nonclinical work sits in it

This page sets out the sequence a programme follows in the United States and names the regulation governing each step, so that the articles in the other sections can be placed against it. The most frequently misdescribed step is the transition from nonclinical to clinical work, which is addressed directly below.

An IND is not approved

The application containing the nonclinical package goes into effect 30 days after the FDA receives it, unless the agency places the study on clinical hold within that period.[S2] There is no approval step and no approval letter, and describing one is a common error in material written for other markets. What the application must contain in its pharmacology and toxicology section is set out in the regulation,[S1] and what studies are needed before each clinical phase is addressed by the general nonclinical safety guidance.[S4] The clinical work that follows is divided into three phases by regulation,[S3] and is conducted under the regulations governing informed consent and institutional review.[S5]

About this section

These are independent editorial articles for people who commission nonclinical work in the United States. They cite primary sources — the Code of Federal Regulations, FDA guidance documents and peer-reviewed literature — and state where a claim could not be verified. They do not recommend any laboratory, and this site receives no compensation from any organization described in it. Last reviewed: September 4, 2026.

References

  1. 21 CFR 312.23(a)(8) — IND content and format: pharmacology and toxicology information, eCFR. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-B/section-312.23 (accessed 2026-09-03)
  2. 21 CFR 312.40 — IND goes into effect 30 days after FDA receives it unless placed on clinical hold, eCFR. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-B/section-312.40 (accessed 2026-09-03)
  3. 21 CFR 312.21 — Phases of an investigation, eCFR. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-B/section-312.21 (accessed 2026-09-03)
  4. FDA — ICH M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m3r2-nonclinical-safety-studies-conduct-human-clinical-trials-and-marketing-authorization (accessed 2026-09-03)
  5. 21 CFR Part 50 (Protection of Human Subjects) and 21 CFR Part 56 (Institutional Review Boards), eCFR. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50 (accessed 2026-09-03)

3 Recommended Contract Research Organizations
for Non-Clinical Studies
— by Target goal and Expertise

In non-clinical development, the choice of contract research organization shapes the quality of the data and the time it takes to reach the next decision. Below, three CROs are introduced by the type of study they support: pharmacology (efficacy) studies, safety studies, and pharmacokinetic (PK/PD) studies. Each summary describes the services the company offers so that you can match a provider to your target and development objective.

Pharmacology (Efficacy) StudiesDisease-Relevant Models for
Translational Drug Evaluation
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/)

SMC Laboratories, Inc.

SMC Laboratories is a specialized non-clinical CRO focused on in vivo pharmacology and efficacy studies using disease-relevant animal models, particularly in fibrosis, inflammation, metabolic diseases, and oncology.

Areas of Expertise
Disease-Relevant Model Portfolio

SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.

Study Design Based on Target Biology

Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.

Support from Target Validation to Proof of Concept

With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.

Discuss your target and development objective with SMC Laboratories to identify an appropriate model and study design.
Safety StudiesComprehensive Safety Assessment for
Preclinical Development
Charles River Laboratories
Reference: Charles River Laboratories official website (https://www.criver.com/)

Charles River Laboratories

Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.

Areas of Expertise
General Toxicology Across Study Designs

Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.

Non-GLP and GLP Study Support

Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.

Integrated IND-Enabling Safety Assessment

Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.

Explore Charles River for integrated toxicology and IND-enabling safety assessment.
Pharmacokinetic (PK/PD) StudiesConnecting Drug Exposure with
Pharmacological Response
Inotiv
Reference: Inotiv official website (https://www.inotiv.com/)

Inotiv

Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.

Areas of Expertise
Pharmacokinetic Characterization

PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.

Exposure–Response Evaluation

Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.

Integrated DMPK and Development Support

Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.

Explore Inotiv for integrated PK/PD, DMPK, and bioanalytical support.
By Therapeutic Area
Disease Animal Models
and Reviews
Proven Capability, Expertise and Track Record
Top 3 Non-Clinical CRO Services