What We Offer
Arkin Consulting Group offers comprehensive FDA and ISO regulatory, quality and clinical consulting services including:
Quality Assurance Validation & Compliance
ACG provides consulting services for the following:
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Quality Assurance & Compliance
- Audits (GMP/QSR, GxP, ISO, etc.)
- MDR, Complaint Systems
- Traceability
- Part 806 Response & Resolution
- Recall Response & Resolution
- FDA Warning Letter
- QSIT, HACCP
- Risk Management
- Root Cause Analysis
- Quality Systems Development
- Quality System Audits
- ISO 13485:2003
- CMDR, CMDCAS
- Design Control Development & Audits
- Verifications & Validations
- CE-Mark
- Packaging, Sterilization
- Labeling
- GMP/QSR Development
- Software Testing
- Other Compliance Issues
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Validation Consulting & Verification
- Development of Master Plans
- Protocol Development
- Process Validations
- Development of Master Plans
- Protocol Development
- Process Validations
- Software (IQ/OQ/PQ)
- Software Requirements Specifications
- Software Test Planning and Protocols
- System Testings
- SOP development
- Training
- Validation Report Package