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​Resources for Global Compliance & Regulatory Submissions

PharmaLogika understands that the first step is sometimes the hardest. Finding the right resource in a global market can be daunting. If you don't know where to look for the right information, you will not succeed. The following links are provided to assist you in your search for regulatory compliance guidance (please review our Terms of Use, Privacy Policy, and Permissions pages for important information).

​United States

U.S. Food and Drug Administration
FDA Guidance Documents for Regulated Industry
Search CFR Title 21 Database
Guide to Inspections of Quality Systems
Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach
U.S. Department of Labor Occupational Safety and Health Administration

Canada

Health Canada
Health Protection Branch (Health Products and Food Branch)
Drugs and Health Products Legislation and Guidelines
Public Health Agency of Canada 

Europe and the United Kingdom

European Medicines Agency (EMeA)
Medicines and Healthcare products Regulatory Agency
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

​Australia and New Zealand

Australia New Zealand Therapeutic Products Authority
Therapeutic Goods Administration
Medsafe

​Brazil

National Health Surveillance Agency (Anvisa)

China

State Food and Drug Administration

Iceland

Icelandic Medicines Control Agenc

India

Central Drug Standard Control Organisation(CDSCO)
Presentation on Drug License Audit Process in India

Japan

Ministry of Health, Labour and Welfare (Japan

Singapore

Health Sciences Authority

​Switzerland

​SwissMedic - Swiss Agency for Therapeutic Products

World Health Organization

Members Countries of WHO
Essential Medicines and Health Products

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  • Home
  • Books
    • GxP Concise References
    • FDA Inspections and Compliance
    • Military Medical Manuals
    • Patient Workbooks
  • Services
    • Quality & Regulatory
    • Operations & Business
    • Clinical Studies & Product
    • Corporate Governance
    • Consulting Engagements
    • Remediation & Implementation
  • Resources
  • Blog
  • Contact Us
    • Educators
    • Bookstores
    • Terms of Use
    • Privacy & Permissions