Pharmaceutical Industry ATG
Download a .pdf of the complete ATG here: Pharmaceutical ATG
Link to the IRS website version here: Pharmaceutical ATG
The IRS published this revised ATG on 4/30/04.
TABLE OF CONTENTS:
1. Preface and Overview
2. Summary of Recommended Audit Procedures
3. Overview of IRC Sections 174 and 41
4. Product Development Process
a. Stage One – Preclinical/Discovery Research
i. Introduction
ii. Documentation
iii. Preclinical Departments
1. Biology
2. Chemistry
3. Pharmacology and Toxicology
4. Drug Metabolism
5. Protein Discovery
b. Stage Two – Clinical Development
i. Introduction
ii. Clinical Departments
1. Pharmaceutical Development
2. Analytical Chemistry
3. Biostatistics
4. Pharmaceutical Technology Development
5. Drug Safety Assessment
6. Clinical Research and Development
c. Stage Three – Regulatory Review
i. Department – Regulatory Affairs
d. Stage Four – Post-Marketing
i. Introduction
ii. Departments
1. Medical Affairs/Services
2. Drug Surveillance
5. Related Departments
a. Clinical Applications
b. Marketing
c. Computer Support
Exhibit A – Documentation Guidelines
Exhibit B – Hypothetical Organizational Chart
Exhibit C – Departmental Reporting Structure
Exhibit D – Research Credit Wage Issue Chart (See “Using Exhibit D”)
Download a .pdf of the complete ATG here: Pharmaceutical ATG
Link to the IRS website version here: Pharmaceutical ATG
