Aclairo Pharmaceutical Development Group
Aclairo is committed to delivering independent and objective nonclinical and regulatory advice to the pharmaceutical industry, leveraging extensive industry experience to help clients succeed in drug development. They offer strategic, scientific regulatory services, and operations support, with a focus on toxicology, regulatory, ADME, and clinical pharmacology.
Industries
Nr. of Employees
small (1-50)
Aclairo Pharmaceutical Development Group
Services
Regulatory strategy, preparation of regulatory applications and responses, and advice on efficient development pathways for drugs and biologics.
Authoring of final study reports, investigator brochures, expert reports, position papers and regulatory submission documents.
Program management and operational support for preclinical programs including study placement, monitoring, and timeline management.
Design and interpretation of ADME/DMPK studies and clinical pharmacology support for early development.
Preparation of GLP-format toxicokinetic and pharmacokinetic reports to support nonclinical study submissions.
High-level product development strategy including program design, prioritization of studies, and pathway identification to advance products efficiently.
Regulatory strategy, preparation of regulatory applications and responses, and advice on efficient development pathways for drugs and biologics.
Authoring of final study reports, investigator brochures, expert reports, position papers and regulatory submission documents.
Program management and operational support for preclinical programs including study placement, monitoring, and timeline management.
Design and interpretation of ADME/DMPK studies and clinical pharmacology support for early development.
Preparation of GLP-format toxicokinetic and pharmacokinetic reports to support nonclinical study submissions.
High-level product development strategy including program design, prioritization of studies, and pathway identification to advance products efficiently.
Expertise Areas
- Nonclinical toxicology
- ADME / DMPK and pharmacokinetics
- Clinical pharmacology (early phase)
- Regulatory strategy and submissions
Key Technologies
- ADME/DMPK assays
- Toxicokinetic / pharmacokinetic (TK/PK) analysis
- GLP study conduct and reporting
- Histopathology