JAH Associates LLC
Expertise in toxicology and drug and medical device development

Pharmaceutical Development Capabilities



Services are offered to help our clients in the following areas:


Design of regulatory strategies for preclinical and clinical development


Design and execution of complete preclinical development programs, including toxicology, drug metabolism and pharmacokinetic studies


GLP audits of Contract Research Organization sites for preclinical studies


Protocol development, study placement and monitoring, report writing and reviews of preclinical programs


  • Toxicology
  • Pharmacology
  • Pharmacokinetics
  • Pharmacodynamics
  • Absorption, Distribution, Metabolism and Excretion


Preparation of reports and other documents for regulatory submissions or inclusion in peer-reviewed journals


Investigator Brochure creation


Pre-IND meeting preparation and conduct


IND preparation and review


Regulatory authority correspondence


Preparation for funding or other business-related meetings


Design of mechanistic studies to understand toxicities encountered during development


Project Management


Design and execution of Clinical Trials