AmoSey Inc.

ON
sharavathip@gmail.com

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Services

Regulatory, Quality and Compliance Solutions

  • Regulatory Services

    We provide professional services, consultation & training in the following sectors:

    • Drug Products            
    • Biologics
    • Medical Devices
    • Natural Health Products
    • Veterinary Products
    • Nutraceuticals
    • OTCs
    • Cosmetics
    • Food Products
    • Disinfectants
    • Pesticides
    • Consumer and Personal Care
    • API(Bulk Pharmaceuticals)
  • Quality Solutions

    We provide professional services, consultation and training in the following Pharmaceutical and Biotech Quality areas.

    • GMP Audits
    • Quality Systems
    • Manufacturing
    • Lab and Analytical Methods
    • Gap Analysis and Remediation
    • Remediations- 483s and Health Canada Observations
    • Deviations and Incidents
    • Failure Investigation
    • CAPAs
    • Complaint Handling and Recall
    • CMC Change Management
    • Batch Production Records
    • QA Release
    • SOPs and Documentation
    • ISO 13485 and ISO 9001
    • Risk Assessment
    • Inspection Readiness
    • Validation
  • Validation

    We provide validation services in the following areas:

    • Master Plan Development
    • Validation Compliance
    • IQ, OQ and PQ Execution
    • Protocol and Report Preparation
    • Audit

     

    Validation Services include:

    • Water System Validation
    • Equipment Validation
    • Facility Validation
    • Utilities Validation
    • Analytical Method Validation


More on Regulatory Services

We provide the following services to all the above mentioned categories: 

  • eCTD Submission
  • Electronic Submissions for non-CTD Submissions
  • NEES
  • Scientific and Technical Writing
  • Medical Information
  • Clinical Research
  • Global Product Conformance
  • Drug Master Files
  • Claims Substantiation
  • Regulatory Compliance
  • Product Life Cycle Management
  • Post NOC Changes
  • Labelling
  • Advertising and Promotion
  • Global Processes and System Integration
  • Pharmacovigilance (Adverse Event Reporting)
  • CE Marking
  • 510k Applications
  • ISO - CMDCAS Certifications
  • NDS/SNDS/ANDS/ABNDS Submissions
  • TMA's (for food products)
  • Site License Applications
  • Establishment Licensing (Drugs & Devices)
  • NHP Product Licence Applications
  • DIN Applications
  • Cosmetic Notifications
  • Regulatory Gap Analysis and Strategy



 

 

 

Copyright 2014 Amosey Inc. All rights reserved.

ON
sharavathip@gmail.com