Name

Aclairo Pharmaceutical Development Group

Legal name

Aclairo Pharmaceutical Development Group, Inc.

Website

https://aclairo.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

11–50 employees

Ownership category

akta.pro rank

Product category

Pharmaceutical Consulting Services

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Preclinical CROs (Discovery/Pharmacology/DMPK) (HLAGAAAB)

akta.pro secondary industries

Clinical CROs (Phase I–IV) (HLAGAAAA), Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH)

Keywords

• Pharmaceutical consulting services
• Nonclinical drug development
• Clinical pharmacology advisory
• Regulatory writing services
• Toxicology consulting

Headquarters

HQ city

Vienna

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. Consulting Services: Professional consulting fees for nonclinical development strategy, toxicology, DMPK/TK, clinical pharmacology, cell and gene therapy, and regulatory writing services. Revenue generated through service engagements with pharmaceutical and biotech companies.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Aclairo provides expert consulting services for nonclinical drug development and clinical pharmacology for human therapeutics. The firm delivers eight integrated service areas spanning cell and gene therapy, clinical pharmacology, DMPK/TK, drug development operations, drug development strategy, nonclinical pharmacology, scientific and regulatory writing, and toxicology. Engagements are tailored to pharmaceutical and biotech clients ranging from early-stage companies to large multinationals, covering everything from IND-enabling studies through regulatory submissions to FDA and global health authorities.

Product overview

Aclairo Pharmaceutical Development Group offers a unified portfolio of expert consulting services for nonclinical drug development and clinical pharmacology. The core offering consists of eight integrated service areas: Cell and Gene Therapy Consulting (CGT modalities including AAV, lentivirus, gene editing, and cell therapies), Clinical Pharmacology Consulting (PK/PD, dose selection, regulatory submissions), Nonclinical DMPK/TK Services (ADME, bioanalytical methods, human dose projections), Nonclinical Drug Development Operations (CRO oversight, study monitoring, project management), Nonclinical Drug Development Strategy Consulting (regulatory strategy, gap analysis, program planning), Nonclinical Pharmacology Consulting (on/off-target effects, safety pharmacology), Scientific and Regulatory Writing Services (submission-ready documents for FDA and global health authorities), and Toxicology Consulting (safety pharmacology, genetic toxicology, general toxicology, carcinogenicity). These services are designed to work together, enabling clients to progress therapeutics from early development through IND-enabling studies to regulatory submissions and market approval. The company was founded in 2004 by ex-FDA regulators and has over 350 years of combined drug development experience.

Differentiator

Problem solved

Functional benefit

Products and services

• Cell and Gene Therapy Consulting Strategic advice, program support, and regulatory writing for cell and gene therapy modalities including AAV, lentivirus, LNP-delivered nucleic acids, in vivo and ex vivo gene editing, and cell therapies. Supports nonclinical strategy, regulatory planning, study design, and data interpretation for viral and non-viral delivery systems serving organizations developing human therapeutics.
• Clinical Pharmacology Consulting Guidance, analysis, and reporting integrating pharmacokinetic, pharmacodynamic, dose selection, exposure response, drug interaction, and special population assessments to guide safe and effective drug use. Supports regulatory submissions including pIND, IND, NDA, CTD, BLA, and 510k for pharmaceutical and biotech clients developing human therapeutics.
• Nonclinical DMPK/TK Services ADME insights and guidance supporting program advancement, including pharmacokinetic analysis, toxicokinetics, bioanalytical method development, human dose projections using allometric scaling, MABEL, and IVIVE approaches, and exposure margin calculations. Designed for organizations developing human therapeutics requiring nonclinical drug metabolism and pharmacokinetic expertise.
• Nonclinical Drug Development Operations Operational support including study monitors, CRO oversight, day-to-day communication with contract research organizations, on-site toxicology study monitoring, protocol development, data review, and report finalization activities for pharmaceutical and biotech clients running nonclinical drug development programs.
• Nonclinical Drug Development Strategy Consulting Development of comprehensive nonclinical strategies tailored to specific programs, indications, and regulatory pathways. Includes program assessment, gap analysis, strategic planning, and ongoing support through study execution and regulatory interactions for organizations developing human therapeutics.
• Nonclinical Pharmacology Consulting Expert guidance to characterize on- and off-target effects of drug products and meet regulatory expectations. Supports dose selection, species justification, special patient populations, and identification of potential off-target toxicities across small molecules, biologics, and cell/gene therapies for pharmaceutical and biotech clients.
• Scientific and Regulatory Writing Services Preparation of high-quality, submission-ready documents for regulatory interactions and scientific communication. Supports INDs, CTAs, BLAs, NDAs, Investigator Brochures, pharmacology reports, DMPK reports, FDA meeting packages, and primary research manuscripts. Documents are developed in alignment with FDA and global health authority guidances for organizations developing human therapeutics.
• Toxicology Consulting Expert toxicology services spanning safety pharmacology, phototoxicity, genetic toxicology, general toxicology, carcinogenicity, developmental and reproductive toxicology, and juvenile toxicology. Supports strategy development, study design, conduct, interpretation, and regulatory submissions for global success for organizations developing human therapeutics.

Segments4 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

One partnership is on record.

• Experimental Pathology Laboratories (EPL)coreStrategic or Co-development Partner · 1 January 2018Aclairo is a wholly owned subsidiary of Experimental Pathology Laboratories, a private, employee-owned company. This acquisition in 2018 allows Aclairo consultants access to all of EPL's specialized pathology services and provides EPL clients with strategic advice from Aclairo.

Scale indicators3 records

Recent moves10 records

Expansion highlights5 records

Direct peers

• Nuventra Pharma Sciences: Specialty clinical pharmacology and pharmacokinetic consulting firm serving pharma and biotech with drug development strategy, modeling, and regulatory support — directly comparable services, target clients, and boutique scale as Aclairo.
• Biologics Consulting Group: Regulatory and scientific consulting firm staffed heavily by former FDA reviewers providing CMC, nonclinical, and clinical consulting to biologics developers — closely mirrors Aclairo's FDA-veteran model and regulatory advisory offering.
• Halloran Consulting Group: Biopharma consulting firm offering regulatory strategy, quality, clinical operations, and drug development advisory to pharma and biotech sponsors — overlaps with Aclairo's regulatory strategy and nonclinical development consulting services.
• PharmApprove: Regulatory strategy and communications consultancy helping sponsors prepare for and navigate FDA interactions including INDs and advisory committees — directly comparable regulatory advisory positioning to Aclairo's regulatory writing and FDA-interaction services.

Broad incumbents

• ProPharma Group: Full-service regulatory, compliance, and scientific consulting firm serving pharma across the product lifecycle — broader portfolio than Aclairo but adjacent specialty consulting for regulatory and drug development work.
• Charles River Laboratories: Large global CRO offering extensive nonclinical drug development, safety assessment, toxicology, and DMPK services across small molecules and biologics — a much broader incumbent that overlaps with Aclairo's nonclinical safety and DMPK consulting core.
• IQVIA: Global CRO and life sciences services firm providing clinical, regulatory, and drug development consulting across the full development pipeline — broader incumbent with regulatory and clinical pharmacology advisory offerings that overlap with Aclairo's scope.
• Labcorp Drug Development (Fortrea): Large CRO providing nonclinical, clinical pharmacology, and regulatory services to pharma and biotech — directly overlapping preclinical, clinical pharmacology, and regulatory writing capabilities at much larger scale.
• Parexel International: Global CRO with deep regulatory and clinical development consulting services including nonclinical strategy — broader portfolio with overlapping regulatory and drug development advisory offerings to the same pharma/biotech client base.
• Worldwide Clinical Trials: Mid-to-large CRO providing clinical pharmacology, regulatory affairs, and drug development consulting services to pharma and biotech — overlapping client base and adjacent nonclinical-to-clinical advisory capabilities.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/aclairo-pharmaceutical-development-group-inc.

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Aclairo Pharmaceutical Development Group