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
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
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)
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
Brazil
China
Iceland
India
Central Drug Standard Control Organisation(CDSCO)
Presentation on Drug License Audit Process in India
Presentation on Drug License Audit Process in India
Japan
Singapore
Switzerland
SwissMedic - Swiss Agency for Therapeutic Products