Regulatory Affairs and GMP Services from DSA Consultants

Abbreviated New Drug Submissions
Access to Information Requests or Responses
Adverse Drug Reporting
Adverse Reaction Reporting
Analytical method validation
Annual Product Reviews
Assessments of Change Control
Audits
Batch Document Review
Biologics
Calibration Programs
Carrier qualification
Category IV Submissions
Cleaning Validation
Clinical Trial Applications
Cold Chain
Computer Validation
Controlled Drugs
Controlled Substances
Cooler Mapping
Cooler Validation
Cosmetic Notifications
Cosmetic Registrations
Cosmetic Regulations
Dealer’s License/Permit
Devices
Disinfectants
Documentation Review
Domestic Substances List
Drug Identification Number
Drug Submissions
DSL Registration
Due Diligence Assessments
Equipment Qualification
Equipment Validation
Establishment Licenses (Licenses)
Establishment Licensing
Facility Qualification
Food and Drug Regulations
Food and Drugs Act
Formulary Listing Submissions
Freeze thaw Studies
Freezer Mapping
Freezer Validation
GAP Analysis
GCP Audits
GCP Training
GLP Audits
GLP Training
GMP Audits
GMP Training
Good Manufacturing Practices
Guide 0069
HAACP Audits
HACCP Training
Health Canada
Herbal Medicines
Herbal Remedies
HPFBI Inspection Preparedness
ICH Guidelines
Import Permits
Importer of Record
INCI Labelling Review
Incubator mapping
Incubator validation
Investigational New Drug Submission
Labelling Review
Labelling Standard
Legal Agent
Submissions
Laboratory Audits
Mandatory Problem Reports
Manufacturing Site Audits
Mapping
Market Access
Medical Device Regulations
Narcotic Dealer’s license
Narcotic Dealer’s license
Narcotics
Natural Health Product Regulations
Natural Health Products
Natural Product Number
NC Submission
New Drug Submissions
NHP Submissions
Notifiable Change Submissions
Packaging qualification
Packaging Validation
PMRA Submissions
Precursor A Submissions
Precursor B Submissions
Private Payer Plans
Process Validation
Product Assessment
Product License Applications
Product License Applications
Product Registrations
Product Releases
QC Release of Products
Quality Assurance
Quality Assurance Reports
Quality Control
Reduced Testing Programs
Regulation Interpretation
Regulatory Affairs
Reimbursement
Review of Stability Protocols or Data
Review of Validation Protocols or Data
Risk Management
Rx to OTC
Sanitation Programs
Self-Inspections
Shipping Container Mapping
Shipping Container Validation
Shipping Route Qualification
Shipping Route Verification
Simulated HPFBI Inspections
Site Licenses
Site Licensing
Site Licenses
Site Licensing
Site Reference Files
Six Sigma
Specification Reviews
Stability Data Summaries
Stability Programs
Standard Operating Procedures
Statistical Analysis
Statistical Process Control
Storage area mapping
Submission Preparation
Supplemental Abbreviated New Drug Submissions
Supplemental New Drug Submission
Temperature Mapping
Test Methods
Third Party Audits
Training Programs
Transportation vehicle mapping
Validation Programs
Warehouse Audits
Warehouse Mapping
WHO Export Certificates
… and many more