GMP, clinical trial, pharmacovigilance, drug approval, and life sciences quality system regulations for pharmaceutical manufacturers and biotech firms. AuditDSS decomposes 68 regulations into 37,787 individually testable obligations across 10 jurisdictions with 4-axis risk scoring.
HHS-OIG, FDA, and CMS are pursuing record-breaking settlements against manufacturers, distributors, and PBMs. A single False Claims Act case can exceed your entire annual revenue.
$12.5B
HHS-OIG pharma enforcement
Purdue Pharma $8.3B, Novartis $729M — off-label promotion and kickback schemes drive the largest penalties in federal history
$557M
FDA enforcement actions
Ranbaxy paid $500M alone for GMP data integrity fraud — manufacturing violations trigger criminal prosecution
$747M
CMS program integrity
Tuomey Healthcare paid $237M for Stark Law violations — physician arrangements are a compliance minefield
68
Regulations covered
3,837
Rules decomposed
37,787
Obligations scored
10
Jurisdictions
10 jurisdictions, 68 regulations
From FDA current Good Manufacturing Practices to Anti-Kickback safe harbors, from 21 CFR Part 11 electronic records to DEA controlled substance schedules — AuditDSS decomposes every regulation into independently testable obligations.
Score your cGMP program, data integrity controls, and pharmacovigilance obligations in a single assessment. Know exactly which FDA 483 observation is waiting to happen before the inspector arrives.
ICH-GCP, 21 CFR Parts 50/56/312, and informed consent requirements decomposed into auditable obligations. Stop relying on CRO assurances — verify compliance yourself.
Drug pricing transparency, rebate pass-through requirements, and Anti-Kickback safe harbors scored at the obligation level. PBM regulation is accelerating — get ahead of it.
All 68 regulations applicable to pharmaceuticals & life sciences, grouped by theme. Every regulation links to its detailed obligation breakdown.
Therapeutic Goods Administration
European Parliament and Council
Food and Drug Administration
Food and Drug Administration
International Council for Harmonisation
Medicines and Healthcare products Regulatory Agency
Office of the Australian Information Commissioner
Autoridade Nacional de Proteção de Dados
California Attorney General / California Privacy Protection Agency
European Data Protection Board
HHS Office for Civil Rights
Data Protection Board of India
Personal Data Protection Commission
Information Commissioner's Office
Cyber and Infrastructure Security Centre
Joint Committee of European Supervisory Authorities (EBA/ESMA/EIOPA)
Center for Internet Security
European Union Agency for Cybersecurity
National Institute of Standards and Technology
National Institute of Standards and Technology
PCI Security Standards Council
National Cybersecurity Authority
Cybersecurity and Infrastructure Security Agency
General Services Administration
HITRUST Alliance
American Institute of Certified Public Accountants
HHS Office of Inspector General
European Parliament and Council
US Department of Justice — FCPA Unit
Agence Française Anticorruption
Securities and Exchange Commission
Serious Fraud Office
Environmental Protection Agency
Environmental Protection Agency
European Parliament and Council
European Parliament and Council
Environmental Protection Agency
Australian Securities and Investments Commission
European Parliament and Council
International Sustainability Standards Board
International Sustainability Standards Board
Securities and Exchange Commission
Safe Work Australia
European Parliament and Council
Occupational Safety and Health Administration
Occupational Safety and Health Administration
Health and Safety Executive
Fair Work Commission
Australian Border Force
Ministry of Human Resources and Social Development
Equality and Human Rights Commission
Advisory, Conciliation and Arbitration Service
Independent Anti-Slavery Commissioner
U.S. Department of Labor — Wage and Hour Division
U.S. Department of Labor — Wage and Hour Division
Equal Employment Opportunity Commission
American Institute of Certified Public Accountants
Information Systems Audit and Control Association
Committee of Sponsoring Organizations of the Treadway Commission
Cloud Security Alliance
International Auditing and Assurance Standards Board
International Auditing and Assurance Standards Board
American Institute of Certified Public Accountants
American Institute of Certified Public Accountants
Answer a few questions about your business. Get a complete compliance program — policies, procedures, and operational forms — tailored to your risk profile and mapped to every obligation. Ready in minutes.
Pharmaceuticals & Life Sciences Compliance Policy
Risk-calibrated · 10–15 sections
Operational Procedures
Step-by-step · Staff-ready
Forms & Checklists
Operational forms · Ready to use
Score your existing policies against 37,787 obligations — or generate a complete compliance program tailored to your business in minutes.