- Certification Standards:
- Pharmaceutical manufacturer -certificate of Good Manufacturing Practice (GMP)
- Audited by HPRA (Health Products and Regulatory Authority of Ireland) to EU directive.
- ISO 9001:200
- ISO 13485: 20
- Raw material and packaging suppliers audited to GMP and /or ISO9001:2008 standard by Medentech personnel.
- Medentech operates a fully audited batch tracking system and retains samples of all batches for shelf-life plus one year.
- Validated manufacturing processes.
- Complete quality control analysis for all batches according to customer specifications
- Stability studies conducted according to ICH (International Committee on Harmonisation) Guidelines.
- Has a team of highly qualified technical personnel to PhD standard.
- NSF Approved for 10mg per litre. ( Not all products NSF approved0