axsource_logo.jpg
About US: AxSource Consulting Inc. services include Clinical Affairs, Regulatory Strategy & Submissions to FDA, EMA, MHRA, Health Canada and TGA, eCTD Publishing, NHPs, Nutraceuticals, Cosmetics, Medical Cannabis, Compliance services (MDSAP, ISO 13485, GLP, GCP, GMP, GDP & GPP), Training, Pre-Inspection readiness, QMS and Quality Audits, Pharmacovigilance, Process & Software Validation and Litigation Support. Microsoft ERP Quality & Compliance software solutions developed - QCS™ for pharmaceuticals, devices & OCS™ for Medical Cannabis.
Web Site: http://www.axsource.com
Address:

336 Bronte Street South, Suite 225
Milton, ON L9T 7W6
Canada

Contact:

Navneet Sekhon
President
Phone: (905) 854-6059
Email: nav.sekhon@axsource.ca

Georgaphic Areas: Australia
Canada
United States
Europe
United Kingdom
India
Quality & Compliance Services (worldwide)
Business Type: Regulatory Consulting Services
eCTD Publishing Services
Quality & Compliance
Pharmacovigilance
Process Validation
Software Validation (ERP, Device, LIMS, Mfg.)
Environment, Health & Safety
Pharmaceutical Software Development
Microsoft Software Professional Services
Litigation Support
Products Active Pharmaceutical Ingredients
Biologics
Biosimilars
Combination Drug-Device
Medical Devices (Imaging, Software, IVDD, etc.)
New Drugs /Orphan Drugs
Generic Drugs
Natural Health Products/ Nutraceuticals/OTC
Medical Cannabis
Cosmetics
Professional Responsibility (Production) Device Software
ERP Software
QCS™ - Quality & Compliance
OCS™ - Organic Compliance Software (Cannabis)
Professional Responsibility (Regulatory Process) eCTD Publishing (Health Canada, EU, MHRA, TGA)
Regulatory Submissions
Biological License Application (BLA)
Investigational New Drug (IND)
Drug Applications (NDA/S, ANDA/S, SNDA/S, 505(b)(2))
Good Laboratory Practices (GLP)
Good Clinical Practices (GCP)
Clinical Monitoring
Good Manufacturing Practices (GMP)
Good Production Practices (GPP)
Good Distribution Practices (GDP)
Good Pharmacovigilance Practices (GVP)
Good Agricultural & Collection Practices (GACP)
MDSAP
ISO 13485 Certification
De Novo Applications
Premarket Approval (PMA)
Premarket Notification (510k)
Investigational Device Exemption (IDE)
Investigation Testing Authorization (ITA)
Establishment Registration
CRO Services
Other Professional Responsibility Litigation Support (Expert opinions, Strategic support)
Terms & Conditions
Quality Agreements