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