Regulatory & Quality Services

Microsoft Dynamics ERP For Quality and Compliance

At AXSource, we differentiate between Consulting and Professional Services in order to cater to our clients based on their individual requirements.We provide complete support in pre-market product & facility authorizations, GMP/GLP/GCP/GDP compliance systems, post-market surveillance activities, and regulatory agency inspection readiness (e.g. FDA, Health Canada, MHRA etc.).

Our true “consulting” service starts from our in-depth analysis of your unique business situation by our industry experts who can identify and mitigate potential business risks and create a cost-optimized project plan. When you choose our “consulting” offerings, be comfortable in knowing you are getting top notch expertise to assist you in leaping the milestones in your sales & marketing strategy.

We take pride in responding to clients with quality execution and on-time project delivery. Our consultants and partners have on average over 20 years experience. They are required to meet the highest standards of professional & ethical performance and strive to continuously improve. Each consultant or partner must comply with our governance policies and procedures in order to ensure that customers are completely satisfied with our services.

When you choose our “professional” regulatory & quality offerings, we can undoubtedly provide cost-effective solutions for your short or long term projects.

Get in touch

We have conducted business in many countries and languages. Feel free to contact us today!

Our clients may be researchers, CROs, diversified healthcare companies such as pharmaceuticals, contract manufacturers, testing laboratories, medical device & Natural health products (NHP) manufacturers, logistics operations, importers, distributors, law firms, regulatory consulting group, training companies, universities and research institutions.

AXSource Consulting has customers all around the world. Our goal has always been to provide our clients with unique and distinctive solutions that reduce time and cost while ensuring compliance.

Write to us today to obtain more information. We will gladly support you.

“We recently used AXSource Consulting to conduct our Self-Inspection program and were impressed with the depth of up-to-date industry and regulatory (both Canadian and international) knowledge. All timelines were met and all dealings were professional. Our expectations were exceeded and we would definitely consider using AXSource in the future.”

Eleni D, Senior Quality Systems Manager
  • regulatory affairs
  • quality & compliance
  • gap analysis
  • quality assurance/control
  • pre-clinical / non-clinical studies
  • clinical studies
  • regulatory inspections (i.e. FDA PAIs, pre-licensing)
  • quality management systems development under GMP, GLP, GCP & GVP
  • consultant audits (GUI-0080) for submission to Health Canada
  • process and equipment validation
  • process improvement & scorecards
  • Regulatory Quality Business Insights (RQBI)
  • ISO systems implementation & certification (ISO 13485, ISO15189, etc)
  • ISO Audits & Quality Audits (GxPs)
  • mock inspection audits
  • customized software development and implementation
  • software validation per FDA’s system development life cycle (SDLC) approach
  • validation engineering services
  • strategic planning
  • GMP training & development
  • pharmacovigilance
  • governmental exemptions
  • litigation support
  • expert opinions