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 |
Contact us to find out more about our regulatory consulting services or download a free copy of our DSA Whitepaper on marketing a health care product in Canada.
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