AXSource Consulting is passionate about training and development. We will ensure that our clients in the health products industry can maintain internal compliance and are successful in regulatory authority inspections. Depending on whether your business is a small start-up or large, multi-national company, you may have need of professional training in one or more of the following areas, in a global setting.
- Regulatory Affairs – product & facility changes needing regulatory filings
- Quality – product & system quality maintenance
- Good Laboratory Practices, Good Clinical Practices, Good Manufacturing Practices, Good Pharmacovigilance Practices, Good Documentation Practices (GLP, GCP, GMP, GVP, GDP)
- Computer System Validation (CSV)
- Pharmacovigilance – safety complaint handling & reporting (clinical & post-market adverse drug reactions, medical device problem reports)