Quality Systems
4985 Rosewood Lane
Plymouth, MN 55442
Phone: (612) 839-3887
Contact: Randall Tlachac
Biomedical Field
Consulting and Management Services, for Medical Devices, Pharmaceuticals and Combination Products, Cell- and Tissue-Based Therapies
Business
Services
Services
Biomedical industry consulting services
- Quality Systems Development and ISO 9001/13485 Registration
- Device Design and Development Engineering
- Pharmaceutical Development
- GLP, GCP, GTP and GMP Implementation
- Regulatory Submission support including PMA, 510K, IND, IDE, NDA, ANDA and Drug Master Files
- Biomedical Facility Design and Validation
- Operations Management Support
- Validation Services
- Quality Control Laboratory Development and Support
Technical Support Contact
E-mail: Randall Tlachac
Quality Systems Homepage