AmoSey Inc.

ON
sharavathip@gmail.com

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