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DirectoryBusiness & Technical ServicesResearch & DevelopmentMuttenzPreclin Consulting GmbH
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Preclin Consulting GmbH

Summary

About the company

Preclin Consulting GmbH is a consultancy for toxicology, pathology and non‑clinical safety assessment. Services include preclinical development planning, design and monitoring of toxicology studies (genetic toxicology, safety pharmacology, reproductive and juvenile studies), pathology peer review and report assessment, calculation of human safety factors, and support for non‑clinical regulatory dossiers (e.g. IB, IMPD, CTD sections).

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9
Toxicology Consulting
Toxicology consulting for new chemical and biological active substances, early development plans, Fast-Track programmes for First-in-Human and non-clinical support for clinical development.
Pathology Consulting
Pathology consulting for experimental and toxicology pathology, including Pathology-Reviews, Pathology Peer Review, conduct of study pathology and assessment of toxicity reports.
Safety Assessment and Risk Analysis
Safety and risk assessments of preclinical data, including calculation of the Human Safety Factor and assessment of impurities in active substances and medicinal products.
Preclinical Development Planning
Preclinical development planning for new chemical or biological substances, including support for lead-candidate identification, Mature Products and new formulations.
Regulatory Non-Clinical Documentation
Preparation and review of Investigator’s Brochure, IMPD, non-clinical overview and CTD module 2.6, as well as scientific support with regulatory authorities.
Toxicology Study Design and Monitoring
Design and implementation of toxicology studies, including metabolism, toxicokinetics, genetic toxicology, safety pharmacology and monitoring at CROs.
Reproductive and Juvenile Toxicology
Reproductive Toxicology in segments I, II and III, as well as juvenile animal studies for paediatric clinical investigations.
Translational and Clinical Development Support
Non-clinical support for clinical development, Translational Medicine and technical/scientific support in preparing further development decisions.
Due Diligence Review of Preclinical Dossiers
Due diligence of preclinical dossiers for licensing-in or licensing-out new products, including expert assessment of the available data package.
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Location

Kirschgartenstrasse 2
4132 Muttenz

At a glance

Legal form
Limited Liability Company
UID
CHE-113.460.363
Founded
2007 · 19 years
Last commercial register change
December 14, 2017
Employees
1 to 10

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