AXSource

AXSource Consulting supports Pharmacovigilance Services & Solutions, Audit, Pharmacovigilance Risk Management in Canada for health care industry.

AXSource Consulting Inc. serves Pharmaceutical contract research organizations (CROs), manufacturers and distributors in USA & Canada, etc.

AXSource Consulting’s professional GxP services which includes GxP System Validation, Assessment, Training & Audit Services will provide with cost-effective

AXSource can perform a Regulatory Audit & Compliance Gap Analysis for your organization at any time. Whether you’re in need of an independent self-inspection, an audit of a vendor/sub-contractor/third party,a data integrity audit, or a GMP/ GCP/ GLP/ GVP/ GPP audit, our certified experts can assist you with a single or multi-site Quality Audit.

AXSource Consulting is committed to understanding your unique situation and support a complete FDA Software Validation, Retrospective & Computer System Validation (CSV) program ensuring strict regulatory compliance.

AXSource Consulting uses a lifecycle approach to Health/Canada fda process validation that provides a well-planned, risk-based and cost-effective approach to ensure an effective control strategy for new or marketed products.

AXSource Consulting provides regulatory inspection & audit services which includes GLP, GCP, GVP, GDP, GPP, GACP or GMP audit & Guidance

AXSource Consulting provides you with professional regulatory compliance training in one or more of the following areas GLP, GCP, GMP, GVP, GDP, GPP & CSV

AXSource Consulting’s regulatory due diligence process will support you with the appropriate information to make an informed decision.

AXSource Consulting offers CE Marking for Medical Devices, IVD, AIMD to support and provide consulting services for the entire CE marking process or guidance for certain components

Structured Product Labeling is a labelling format based on XML and Health Level Seven (HL7) SPL standards and controlled vocabularies. Regulatory agencies such as Health Canada and FDA, define SPL rules and Regulations for labelling compliance.

AXSource offers global Pharmaceutical Product Labeling & Promotional services which includes promotion & marketing activites as per country specific labeling requirements

At AXSource Consulting, market access consulting experts are ready to guide you when it comes to regulatory agencies, prices, and reimbursements.

AXSource Consulting offers eCTD Publishing & Submission Services to support regulatory submission compilation and filing in the electronic Comment Technical Document (eCTD) & Non-eCTD electronic Submissions (NeeS) formats.

AXSource provides pharmaceutical regulatory affairs services in canada, US FDA for pharmaceuticals, biologics, active pharmaceutical ingredients (APIs), over-the-counter (OTC), Natural Health Products (NHPs), cosmetics & medical devices.

AXSource consultants provides Pharma Regulatory Affairs Consulting Services with a documented regulatory strategy which defines a path for expeditious approval (including any contingencies), aligns with regulatory agencies, and can be easily communicated to all stakeholders.

AXSource offers Cannabis Consulting & Solutions, Seed to Sale Software to licensed producers of cannabis with all their regulatory compliance needs.