Global Regulatory

Global Regulatory - pharmaceutical, medical device, biotechnology, food, nutraceutical consulting, auditing, training

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For more information , please contact Global Regulatory Inc. at 1-877-843-5251 or email us

Compliance

  • Government Laws, Regulations and Guidelines Compliance
    • US Food, Drug & Cosmetic Act (FD&C)
    • US FDA Good Manufacturing Practices (GMP)
    • US FDA Good Laboratory Practices (GLP)
    • US FDA Good Clinical Practices (GCP)
    • US FDA Medical Device Quality System Regulations (QSR)
    • US FDA CFR Part 11
    • Japanese Ministry of Health, Labor, and Welfare (MHLW) Pharmaceutical Affairs Law (PAL) of 2002
    • HealthCanada CMDCAS
    • Australia Therapeutic Goods Agency (TGA) Therapeutic Goods Act 1989
    • TGA Australian Regulatory Guidelines for Complementary Medicines (ARGCM)
    • TGA Therapeutic Goods (Medical Devices) Regulations 2002
    • Brazil INMETRO
    • European Union CE Marking
    • European Union EEC Directives
    • European Union Medical Device Directives MDD
    • European Union In-Vitro Diagnostic Directives IVDD
    • European Union CEN Standards
  • International Accords, Treaties, and Memorandums of Understanding Compliance
  • Industry Standards, Certifications, License and Guidelines Compliance such as:
    • ISO 9002
    • ICH Standards
    • USP
    • IEEE
    • AST
    • JP
    • BP
    • ANSI
    • HAACP

For more information, please contact Global Regulatory Inc. at 1-877-843-5251, email us or Submit Regulatory Requests for Proposals