Medical Devices compliance management Services
Andes Biotech Life Science
Andes Biotech Life Science Consulting experience is varied working with Listed and Registered Medicines, OTC products, Complementary medicines, Medical Devices, Food Products and Cosmetics.
Let our team of experts assist your organisation with bringing new products to the market, as well as provide specialised regulatory knowledge that will maintain your current product portfolio’s compliance to industry standards, and place the quality of your product where it needs to be.
- Technical file evaluation and compilation
- Conformity assessment and lifecycle management
- Clinical evidence and design examination
We are committed to the success of your products and to help you develop and implement regulatory and quality solutions catered to your needs.
Our team of consultants bring many years of combined experience in Regulatory Affairs, Compliance and Quality Assurance, working with regulatory bodies around the world such as the TGA, Medsafe, FDA, EU Competent Authorities and Notified Bodies, and various global Authorized Representatives with a proven track record of executing techniques in a timely and cost efficient manner.