Overview
AxSource Consulting Inc. provides global clinical, regulatory, compliance, quality assurance, quality control, engineering and IT business solutions to the pharmaceuticals, biologics, natural health product, medical devices, cosmetics, healthcare, information technology and allied industries.
We specialize in start-up operations and new product launches for all your activities in emerging markets. AxSource consists of a team of highly qualified consultants who have committed decades of professional experience to their clients in Canada, USA, Asia, Europe, Mexico and other countries.
Our clients may be researchers, CROs, manufacturers, importers, distributors, laboratories, contract manufacturers, logistics, regulatory consulting group and training companies. We serve as a virtual regulatory provider for many virtual companies.
The Group is exclusively dedicated to providing the following professional & consulting services:
- regulatory affairs & compliance
- quality assurance/control
- pre-clinical/clinical affairs
- regulatory inspections readiness or on-site coordination ( i.e. FDA PAIs, pre-licensing)
- quality management systems development under GMP, GLP & GCP
- consultant audits (GUI-0080) for Health Canada
- process and equipment validation
- process improvement & scorecards
- Regulatory Quality Business Insights (RQBI)
- ISO systems implementation & certification
- Quality ISO & GXP auditing
- Mock audits
- laboratory management
- customized software development and implementation
- software validation per FDA's system development life cycle (SDLC) approach
- validation engineering services
- strategic planning
- medical writing
- In-house GMP training & development
- pharmacovigiliance
- Governmental exemptions and position papers
- Litigation support for healthcare clients