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- Preparation and review of regulatory submissions,
- Registration and conformity assessment applications for TGA
- FDA registrations and listings
- CE marking dossier preparation and review
- Strategic Planning
- Implement integrated ISO 13485 and FDA quality system requirements
(QSR)
- Processes and Systems reviews
- Technical Reviews
- Technical dossier reviews
- Internal audits
- Gap analysis for ISO 13485 Medicine GMP
- Supplier due diligence and assessment audits
- Product labelling reviews
- Advertising Promotional Materials reviews
- Regulatory advice and consulting support for post market requirements
- Training in Medical Device and IVD regulations, FDA QSR, ISO
13485, Medicine GMP, internal auditors
Contact us to find out how our regulatory consultant can tailor
our services to fit your regulatory and quality needs.
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