Pathology Services

Nonclinical Drug Development Strategy

Aclairo consultants have extensive experience evaluating and advising on FDA, DMPK, and pharmacology/toxicology issues encompassing virtually all classes of drugs, biologics, and indications.

We focus on facilitating the successful design of and strategy for your development program focused on program advancement.

Development of a complete nonclinical strategy

Due diligence and gap analysis of existing programs
Regulatory document development and reviews
Provide guidance on Health Authority interactions around complex drug development issues
Construct a nonclinical program minimizing animal use

What sets Aclairo apart is the depth of our expertise. Our specialists bring decades of combined experience, ensuring that every project benefits from the best knowledge in the field.

Nonclinical Drug Development Operations

Our team provides the operational support your company needs to turn strategy into data while ensuring outsourced studies are conducted in alignment with company priorities.

Our Nonclinical Drug Development Operations teams work together to support the planning, conduct, and reporting of nonclinical studies, ensuring that timelines for data are clear and that emerging data from studies are presented in the appropriate context for decision making.

Aclairo offers:

Support consistent with client needs: Aclairo can provide study monitors, toxicologists, senior strategists, PKDM expertise, and pathology support. Work can be distributed to minimize client costs.

On-site study monitoring (as requested) and virtual or on-site laboratory qualification
Timely updates on study progress and protocol amendments
Clear explanations of emerging data
Regular updates to project teams

What sets Aclairo apart is the depth of our expertise. Our specialists bring decades of combined experience, ensuring that every project benefits from the best knowledge in the field.

Discover how Aclairo can support your nonclinical operations with tailored reports and expert-driven recommendations.

Cell and Gene Therapy

Aclairo’s Cell and Gene Therapy group have extensive experience providing strategic advice, program support, and regulatory writing for many modalities, including AAV, lentivirus, LNP-delivered nucleic acids, in vivo and ex vivo gene editing, and cell therapies.

Aclairo CGT consultants can advise on:

Developing an efficient nonclinical package to meet regulatory requirements

Effective briefing documents and questions for INTERACT and preIND meetings
Critical endpoints to include in nonclinical studies
Design and placement of nonclinical studies
Study monitoring

Toxicology

Aclairo has the experience and ability to provide consulting services in toxicology in a cost-effective and timely manner.

We will take the time to listen to your needs and coordinate those with availability and appropriate expertise among our staff of consultants.

Our consultants have extensive experience in small and large pharmaceutical companies, contract research organizations, FDA, and academia. We can help you design, conduct, monitor, edit, and report your toxicology studies to prepare you for global regulatory success.

With expertise in genetic toxicology, general toxicology, carcinogenicity, developmental and reproductive toxicology, and juvenile toxicology, our experts can facilitate product quality assessments (impurities, leachables, excipients) and ADE/OEL to support manufacturing. We can additionally aid the integration of in vitro and in vivo pharmacology and safety pharmacology or abuse liability.

Aclairo consultants routinely help clients with:

Acting as the toxicology project team representative or team leader
Providing strategic and scientific advice
Minimizing animal use in toxicology programs by incorporating appropriate in vitro methods
Authoring or editing regulatory submissions
Designing and implementing overall toxicology strategy
Due diligence and gap analyses
Preparation and attendance for Health Authority meetings
In silico genetic toxicology assessments
Program management for nonclinical studies
Nonclinical study monitoring
Study placement
Study report refinement
Lab qualification site visits

Nonclinical Pharmacology

Many Aclairo consultants have expertise in both pharmacology and toxicology and can provide advice on:

Pharmacology strategy
Development of pharmacologically relevant in vitro and in vivo models
Minimizing animal use in pharmacology studies
Secondary pharmacology strategies appropriate for the modality
Interpretation of off-target risks
Safety pharmacology and incorporation into general toxicology studies

Learn how the experts at Aclairo can help advance your nonclinical pharmacology programs.

Nonclinical DMPK/TK

Our team provides clear, reliable DMPK/TK insights in support of both mechanistic and toxicological developments that assist our clients in making better decisions, allowing for rapid and cost effect program advancement.

We combine proven methodologies and approaches with modern technologies to deliver results tailored to meet your scientific and technical needs. The DMPK/TK team prides itself on providing high quality deliverables and services in a timely and cost effect manner Collectively the team has involvement in over 50 approved NDAs and several hundred INDs involving diverse indications, novel discovery programs, unique routes of administration, and design of delivery systems for various drug entities and therapeutic areas worldwide.

How Aclairo Supports Clients’ DMPK Needs:

Provides clients with strategic guidance, PK/PD technical analysis, and reporting support for clinical and nonclinical developmental programs either alone or as active members of internal project development teams.
Provides direct PK analysis and reporting for early stage nonclinical/Phase1. Phase 2 clinical programs including feasibility assessments, regulatory advancement, and clinical progression.
Recommends and provides the most appropriate data analysis approach for your project, including R, WinNonlin, NONMEM, PCMODFIT, NLMIXR, SAS, etc.

Aclairo provides DMPK support for:

Candidate selection and screening
Full support of in vivo programs
Design and interpretation of in vitro ADME experiments
Protein binding, metabolism, CYP inhibition/induction
Transporter substrate/inhibition etc.
Non-GLP and GLP PK/TK analysis and reporting
- Oversight of bioanalytical method development and validation
- Fully GLP-compliant TK reporting
Regulatory documents PK/PD Analysis
- Pharmacologic and toxicologic modeling
- Modeling and simulation (NCA, Compartmental analysis, POPPK, PBPK etc.)
- Applications including WinNonlin, NONMEM, R, and others
- Mechanistic modeling including PK/PD
Translational Justification
- Human dose and PK projections
- Activity or safety-based dose selection and justification (e.g., using allometric scaling, MABEL, exposure, etc.)
- In vitro-in vivo extrapolation (IVIVE) of interspecies PK or PK/PD relationships
Dose and regimen optimization and justifications
Submission ready materials, summaries, and reports

What sets Aclairo apart is the depth of our expertise. Our specialists bring decades of combined experience, ensuring that every project benefits from the best knowledge in the field.

Contact us today to ensure your nonclinical ADME studies are designed and interpreted with clarity and regulatory readiness.

Clinical Pharmacology

The Aclairo Clinical Pharmacology Team has been involved in several hundred drug development projects providing guidance, analysis, and reporting in support for GLP-, GCP- and nonGLP-compliant filings covering almost all aspects of clinical development worldwide.

The team has comprehensive experience in the conception, execution, and composition of regulatory submissions (pIND, IND, NDA, CTD, BLA, 510k, etc.) to advance regulatory/developmental strategies for both large and small-size pharmaceutical companies and clients.

How Aclairo Supports Clients’ Clinical Pharmacology Needs:

The team provides technical and strategic planning, execution, and oversite in areas such as bioanalytical, PK, PD and in project specific clinical pharmacology studies spanning Phase 0 to Phase 4, functioning as an integral component of the clinical development team.
Activities cover an array of delivery systems, routes of administration, and chemical entities, including small molecule and biologic candidates with conventional or highly innovative novel mechanisms of action.

Aclairo provides clinical pharmacology support for:

Phase I and II Drug Development Activities
- Program design, oversight, and analysis
  - Design and oversight of first-in-human (FIH) studies
  - Biomarker development
  - Drug delivery challenges
  - PK/PD correlations
  - Drug-drug interactions
- Special populations, food effect, BE/BA, etc.
PK/PD Analysis
- Modeling and simulation (NCA, Compartmental, POPPK, PBPK etc.
- Applications including WinNonlin, NONMEM, R, PCMODFIT, SAS amongst others
- Mechanistic modeling including PK/PD
- Integrated parent/metabolite modeling
- Dose and regimen optimization
Translational Justification
- Human dose and PK projections
  - Activity or safety-based dose selection and justification (e.g., using allometric scaling, MABEL, exposure, etc.)
  - In vitro-in vivo extrapolation (IVIVE) of interspecies PK or PK/PD relationships
Registration Dossiers
- Phase 0 to Phase 4 activities
- Program design, analysis, and reporting including regulatory materials to support submissions worldwide (US, EU, AU, Japan, China, and others)

What sets Aclairo apart is the depth of our expertise. Our specialists bring decades of combined experience, ensuring that every project benefits from the best knowledge in the field.

Advance your clinical pharmacology programs with expert strategy and regulatory confidence.

Scientific and Regulatory Writing

Aclairo’s regulatory and scientific writers have extensive experience in researching and writing regulatory documents and position papers.

We focus on the big picture while being attuned to the details. We will work with you to meet your specifications and timelines using your templates and style guide, or our own, to create submission-ready documents. We ensure adherence to relevant guidances for global health authorities, provide consistently high-quality documents, and conduct a quality control (QC) review of each document. We never use artificial intelligence to create scientific or regulatory documents unless specifically requested by the client.

Our regulatory writing services include:

Regulatory submissions for FDA, Canada, Australia, New Zealand, MHRA, Europe, and Asia

Special protocol assessments (SPAs)
Nonclinical sections of Investigator Brochures (IBs)
INDs, CTAs, BLAs, and NDAs
Pharmacology reports based on sponsor data
Technical and scientific review and QC checks of regulatory applications
Primary research manuscripts, position papers and white papers for preclinical, DMPK, and clinical research publications
Literature reviews and summaries
Carcinogenicity Risk Assessments and Study Waivers
Target Liability Assessments
Subject-specific literature searches
GLP study reports
FDA meeting packages
- INTERACT
- Pre-IND
- Pre-NDA/BLA

What sets Aclairo apart is the depth of our expertise. Our specialists bring decades of combined experience, ensuring that every project benefits from the best knowledge in the field.

Discover how Aclairo’s writing team can transform complex data into clear, regulator-ready documents.