PharmaFacts
PharmaFacts specializes in preclinical toxicology, pharmacology, and pharmacokinetics for small molecules and biologicals, including gene therapy, medical device combinations, reformulated, and over-the-counter products. They provide strategic guidance, expert consulting, and support services to help biotech companies meet regulatory requirements, optimize preclinical programs, and advance towards market approval.
Industries
Nr. of Employees
medium (51-250)
PharmaFacts
Services
End-to-end consulting to design and optimize preclinical safety programs covering toxicology, safety pharmacology, and PK/ADME to support regulatory submissions.
Identification and qualification of CROs, prequalification audits, contract guidance, and oversight of CRO-conducted studies to ensure technical and regulatory fit.
Assessment of preclinical or clinical safety signals for organ systems, development of follow-up testing strategies, and contextualized risk-benefit analyses.
Tailored implementation of quality management across GLP/GMP/GCP, SOP development, GAP analysis, and QA audits appropriate to program stage.
Design and oversight of investigative and mechanistic studies, assay development, model selection, and interpretation to resolve safety issues or advance candidates.
Regulatory strategy, pre-IND and agency meeting support, dossier preparation (IB, IND, NDA, 505(b)(2)), and representation in regulatory negotiations.
End-to-end consulting to design and optimize preclinical safety programs covering toxicology, safety pharmacology, and PK/ADME to support regulatory submissions.
Identification and qualification of CROs, prequalification audits, contract guidance, and oversight of CRO-conducted studies to ensure technical and regulatory fit.
Assessment of preclinical or clinical safety signals for organ systems, development of follow-up testing strategies, and contextualized risk-benefit analyses.
Tailored implementation of quality management across GLP/GMP/GCP, SOP development, GAP analysis, and QA audits appropriate to program stage.
Design and oversight of investigative and mechanistic studies, assay development, model selection, and interpretation to resolve safety issues or advance candidates.
Regulatory strategy, pre-IND and agency meeting support, dossier preparation (IB, IND, NDA, 505(b)(2)), and representation in regulatory negotiations.
Expertise Areas
- Preclinical safety assessment
- Toxicology and safety pharmacology
- ADME/DMPK and bioanalysis
- Regulatory strategy and submissions
Key Technologies
- Toxicogenomics
- In vitro screening assays
- Animal model selection and use
- ADME/DMPK assays