Preclinical Development
We design, manage, and document nonclinical programs that get products into the clinic. Our team builds the study plan, selects and oversees CROs, interprets the data, and writes the submission-ready nonclinical package for IND, CTA, and later filings. For devices and combination products, we run the biocompatibility strategy and integrate the evidence into Biological Evaluation Reports and Toxicological Risk Assessments.
Examples of How We Support
These are just a few examples to show what our preclinical support can look like in practice.
Candidate to first-in-human
You need to get from candidate selection to first-in-human and don't have the nonclinical expertise in-house to design a program that satisfies ICH M3(R2), select the right models and species, manage CRO execution, and compile a submission-ready package. You need someone to "own" the plan and the documentation.
Independent nonclinical review
Your nonclinical program was designed by a CRO, but you're not confident the study designs, species rationale, or report quality will hold up in regulatory review. You need an independent assessment and, if needed, someone to restructure the plan and manage the execution differently.
Biologic and ATMP nonclinical
You are developing a biologic or ATMP and need to navigate the specific nonclinical expectations such as relevant animal and disease models, pharmacodynamics and proof-of-concept, biodistribution and persistence, immunogenicity risk, comparability following manufacturing changes, and safety or toxicology assessment. Standard small-molecule approaches do not apply, and the scientific characteristics of your drug candidate determine what is required.
Design a Biological Evaluation Plan according to ISO 10993-1:2025
You have a medical device or combination product and need a risk-based biocompatibility strategy but don't have the in-house expertise to classify the device, design a Biological Evaluation Plan, ISO 10993-1:2025, coordinate testing, and compile submission-ready Biological Evaluation Reports and Toxicological Risk Assessments. You need someone to build the plan, manage the execution with accredited labs, and ensure the strategy and documentation will hold up under MDR and FDA review.
Nonclinical authority query
Your program has received a question from a health authority on the nonclinical side, an unexpected finding or a request for additional data. You need someone who can interpret the question, design the response, and manage any additional studies.
Understanding Preclinical Development
“Preclinical” means different things in different contexts. Some teams use it for early discovery and target identification. Regulators use it more narrowly: the nonclinical evidence needed to justify first-in-human exposure and support later filings.
On this page, preclinical development means the nonclinical package that needs to hold up in regulatory review. That typically covers toxicology, DMPK, safety pharmacology, pharmacodynamics, and for devices and combination products, a risk-based biocompatibility strategy. We cover development end to end, but this page focuses on our preclinical team’s scope: building the plan, managing CROs and labs, interpreting outcomes, and turning results into submission-ready content. For the broader end-to-end view, see the Pharmaceutical Development focus area.
What We Do
Our preclinical team handles the full chain from program design through to submission-ready documentation.
Our Workstreams
We structure our preclinical support into clear workstreams with defined outputs and interfaces.
Non-clinical Program Design
Phase-appropriate program aligned to pathway and timelines. ICH M3(R2) mapping for FIH readiness. Species and model selection rationale. Modality-specific planning for biologics (ICH S6(R1)), oncology (ICH S9), and ATMPs.
Study Management & GLP Oversight
CRO selection, qualification, and setup. Protocol and SOW review. Ongoing study oversight and deviation management. Report QC. GLP audit support.
Toxicology & Risk Assessment
Toxicological evaluations (active substance, excipients, impurities). Environmental risk assessments. Gap analysis against current regulatory expectations.
Submission & Dossier Authoring
EU CTA documentation. CTD Modules 1.6, 2.4, 2.6, and Module 4 authoring and compilation.
Devices & Combination Products
Primary mode of action assessment and classification. Biological evaluation plans (BEPs) and reports (BERs) per ISO 10993-1:2025. Coordination of biocompatibility testing with accredited labs. Design verification and validation support: sterilisation validation, stability studies, reprocessing validation, transport simulation and packaging validation, and manufacturing process validation. Test laboratory selection, protocol review, and results integration into the technical documentation.
Due Diligence & Gap Analysis
Nonclinical data package assessment for licensing or acquisition decisions. Systematic literature reviews. Risk, timeline, and cost implications for remediation.
Where This Fits in the Development Journey
Strategic advice is most impactful early, but the need for it recurs at every point where the plan must be reassessed or the regulatory landscape shifts.
Discovery & Concept
Early nonclinical strategy input: key risks, initial model and species considerations, and what evidence is likely to be expected for the intended use.
Preclinical
Design the phase-appropriate nonclinical program for IND/CTA readiness. Set study sequencing and documentation expectations. Manage CRO execution and ensure reports are submission-ready.
Design & Development
Support changes that affect the nonclinical package (formulation or process changes, device design decisions, comparability questions). Targeted gap assessments and additional studies.
Clinical
Support trial progression with nonclinical justifications (new dose regimens, new populations, protocol amendments). Prepare responses to authority questions requiring nonclinical evidence.
Regulatory Submission & Approval
Author and finalise CTD Module 2.4, 2.6, and Module 4 content. Ensure the nonclinical narrative is consistent, traceable, and aligned with the submission strategy.
Post-Market & Lifecycle Management
Author and finalise CTD Module 2.4, 2.6, and Module 4 content. Ensure the nonclinical narrative is consistent, traceable, and aligned with the submission strategy.
Product Type Considerations
Nonclinical requirements vary substantially by product type. The regulatory frameworks, study designs, and documentation expectations differ, and getting the approach wrong early creates rework later.
Small Molecules
Standard toxicology and safety pharmacology per ICH M3(R2). Frequent focus on metabolite qualification, impurity risk assessment, and exposure margin calculations. Environmental risk assessment for EU submissions.
ATMPs
Conventional animal models may not predict human outcomes. Comparability studies, biodistribution assessments, and vector shedding studies require bespoke designs. Environmental risk assessments and GMO handling plans often needed.
Combination Products
Separate nonclinical requirements may apply to drug and device components. Integration of biocompatibility, extractables/leachables, and pharmacological data into one coherent evidence package.
Biologics
Model selection driven by pharmacological relevance per ICH S6(R1). Immunogenicity considerations affect study design and interpretation.
Medical Devices
Risk-based biological evaluation per ISO 10993, which replaces the prescriptive Table A1 approach with a framework aligned to ISO 14971 risk management. Contact duration, invasiveness, and material characterisation drive the biocompatibility testing strategy. Beyond biocompatibility, device preclinical work includes sterilisation validation (ISO 11135, ISO 11137, ISO 17665 depending on method), shelf-life and accelerated ageing studies (e.g., ASTM F1980), reprocessing validation for reusable devices, and packaging/transport validation (e.g., ISO 11607, ASTM D4169). Each of these generates evidence required for the technical documentation and conformity assessment.
Sample Deliverables
These are typical outputs from our preclinical engagements.
Phase-appropriate nonclinical development plan aligned with the regulatory pathway and clinical program. 
CRO oversight package: protocol/SOW review, vendor monitoring, and report QC checklist. 
GLP audit support package (audit plan, findings log, and CAPA follow-up). 
Toxicological risk assessments covering active substance, excipients, and impurities, including literature-based justifications. 
Environmental risk assessment (scope, data requirements, and prepared CTD Module 1.6). 
Submission-ready nonclinical package: IND nonclinical sections, EU CTA documentation, and CTD Modules 2.4, 2.6, and Module 4. Scientific advice briefing package for nonclinical topics (briefing book, key questions, and justifications). 
Biological evaluation plan (BEP) and biological evaluation report (BER) per ISO 10993-1:2025 for devices and combination products. Example Projects
Illustrative Example
EU Biotech: Nonclinical Program for a Novel Peptide
A mid-size biotech developing a novel peptide had limited internal toxicology expertise. We designed a nonclinical program compliant with ICH M3(R2), selected qualified CROs, monitored GLP studies, prepared nonclinical CTD modules, and managed an EMA scientific advice meeting. The CTA was accepted without major queries.
Illustrative Example
Medical Device Start-up: Biocompatibility and pMoA Classification
A start-up developing an absorbable implant needed to classify the product and demonstrate biological safety. We assessed the primary mode of action to determine that the product was device-led, drafted the pMoA justification, prepared a design verification and biocompatibility plan aligned with ISO 10993-1, coordinated testing, and compiled the biological evaluation report. The technical documentation was accepted by the Notified Body.
Planning a nonclinical program, preparing for IND/CTA, or dealing with a nonclinical question from an authority?
Tell us about your product and timeline, and we’ll outline how we can help.
Speak with an ExpertKey Regulations & Guidance
These frameworks most frequently inform our strategic advice work:
Frequently Asked Questions (FAQ)
What nonclinical studies do I need before first-in-human trials?
ICH M3(R2) sets out the expectations: general toxicity studies (duration aligned with the proposed clinical study), safety pharmacology (core battery), genotoxicity, and toxicokinetic assessments. The specific package depends on the modality, indication, and clinical design. For biologics, ICH S6(R1) applies. For oncology, ICH S9 allows a more flexible approach. We design the program to match the regulatory pathway and clinical plan.
How do I select the right species for a biologic?
ICH S6(R1) requires that the test species be pharmacologically relevant, meaning the product should bind to and activate the target in the animal model in a way comparable to humans. Conventional rodent models are often not appropriate for monoclonal antibodies or fusion proteins. Non-human primates, transgenic models, or surrogate molecules may be needed. We assess relevance, design the species strategy, and document the rationale.
Can I reuse the same nonclinical package for both EMA and FDA?
Core study reports can usually support both regions, but regional differences exist. We design the program to satisfy both regulators and flag where region-specific additions are needed.
What changed with ISO 10993-1:2025?
The sixth edition, published in November 2025, introduced a risk-based evaluation framework closely aligned with ISO 14971. Endpoint selection depends on material characterization, exposure duration, and hazard identification rather than a checklist. The standard also introduces requirements for assessing reasonably foreseeable misuse. We design biocompatibility strategies under the new framework and document the risk-based rationale.
Do you only write nonclinical content, or do you also manage the studies?
We do both. We design the program, select and qualify CROs, write protocols and SOWs, monitor study execution, manage deviations, QC the reports, and then author and compile the submission-ready documentation. We manage the CROs and labs, interpret the results, and handle authority questions on nonclinical topics.
How long does it take to build a nonclinical program for IND/CTA readiness?
Timelines depend heavily on the modality and the complexity of the program. For a standard small molecule, a typical IND-enabling nonclinical program takes 9 to 15 months from study design to final reports. We map the timeline against the clinical plan to identify the critical path.
What preclinical evaluations are needed for medical devices beyond biocompatibility?
Biocompatibility is one part of the device preclinical picture. Depending on the device, you may also need sterilisation validation, stability studies, reprocessing validation, packaging validation and transport simulation, and manufacturing process validation. The specific requirements are driven by the General Safety and Performance Requirements (GSPR) applicable to your device and the expectations of your Notified Body. We define the testing strategy, manage the laboratories, and compile the evidence into the technical documentation.