CapEval Pharma
CapEval Pharma, founded in 2010 by Dr. Olivier Loget, provides pharmaceutical consultancy services in early pre-clinical to clinical development. The company offers expertise in non-clinical safety, toxicology, drug development, and regulatory affairs, supporting clients worldwide including biotech, pharma, and CROs. With over 30 years of experience, CapEval Pharma specializes in project management, due diligence, regulatory dossiers, and scientific training, aiming to translate science into business and ensure regulatory compliance and quality of medicinal products.
Industries
Nr. of Employees
small (1-50)
CapEval Pharma
Archamps, Rhone-Alpes, France, Europe
Services
Consulting to design and implement preclinical programs that support candidate selection and regulatory entry to clinical trials.
Advice and design support for ADME, DDI, PK experiments, metabolite identification and human PK/dose prediction.
Analytical method development, validation and GLP bioanalysis for preclinical and clinical stages, including metabolite ID and stability testing.
Specification, monitoring and interpretation of GLP and non-GLP toxicology and efficacy studies across species with expertise in genotoxicity, safety pharmacology and tumor/CNS models.
Preparation and assembly of regulatory submissions and CMC documentation for Europe and the USA, including responses to agency questions and briefing packages.
Support in developing QA systems, GMP documentation, supplier audits and validation report review to ensure manufacturing and laboratory compliance.
Consulting to design and implement preclinical programs that support candidate selection and regulatory entry to clinical trials.
Advice and design support for ADME, DDI, PK experiments, metabolite identification and human PK/dose prediction.
Analytical method development, validation and GLP bioanalysis for preclinical and clinical stages, including metabolite ID and stability testing.
Specification, monitoring and interpretation of GLP and non-GLP toxicology and efficacy studies across species with expertise in genotoxicity, safety pharmacology and tumor/CNS models.
Preparation and assembly of regulatory submissions and CMC documentation for Europe and the USA, including responses to agency questions and briefing packages.
Support in developing QA systems, GMP documentation, supplier audits and validation report review to ensure manufacturing and laboratory compliance.
Expertise Areas
- Non-clinical development planning
- ADME/PK and DDI assessment
- Analytical method development and GLP bioanalysis
- Toxicology and safety pharmacology
Key Technologies
- LC-MS/MS and LC/MS technologies (triple quad, ion trap, TOF)
- GC/MS and GC chromatographic methods
- HPLC and ion chromatography
- NMR and IR for identification
News & Updates
Non Clinical Development support at BioFit Event in Nice on March 28, 2024.
Video interview at AFSSI Connexions on May 10, 2024.
Renewal of CIR accreditation for three more years as of September 4, 2024.
Renewed for three additional years, enhancing the company's credibility in research tax credits.
Non Clinical Development support at BioFit Event in Nice on March 28, 2024.
Video interview at AFSSI Connexions on May 10, 2024.
Renewal of CIR accreditation for three more years as of September 4, 2024.
Renewed for three additional years, enhancing the company's credibility in research tax credits.