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- Home
- Services
- Laboratory Developed Tests (LDT) and In Vitro Devices (IVDs) regulatory and quality support, strategies and submissions
- IVDR Consulting, Support and Submissions
- Medical Devices Consulting, QMS Development/Implementation, GAP Assessment
- Risk Management (ISO14971)
- Regulatory Support and Submissions
- EU MDR, IVDR, and ISO13485 GAP Assessment
- Post Market Surveillance
- Technical Files, CE marking
- CTAs, IDEs, Q-Submissions, 510K Submissions
- CMC Consultancy, Management, Support, and DMF writing submission
- Quality Systems – GMP, GLP
- Regulatory Affairs Consultancy and Support
- Regulatory Strategies
- Regulatory Submissions (IND, BLA, NDA)
- Regulatory Labeling Regulatory Operations
- FDA Meetings, Responses
- Risk Management
- Validation Consultancy
- Training
- Cosmetics (Labeling, Quality, Registrations – domestic and international, Dossiers)
- Nutrition and Dietary Products (Quality Systems, Facility Registration, Labeling Compliance, Registration, Dossier)
- Cybersecurity, HIPAA Compliance, SOC 2 Certification, Support, and preparation
- Software Compliance – SDLC development
- Combination Products Consultancy, Strategy, and Support
- NYS Compliance and registration (LDTs)
- News
- Contact Us