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Medical Device
Regulatory Affairs
New Product Approval Support
Post Approval Support
Other Regulatory Services
U.S. Agent Services
EU Medical Device Regulations (MDR)
Compliance Assurance
Assessments
Audits
Preparation and Training
Regulatory Agency Action Response
Quality Assurance
Outsourced Quality Support
Medical Device Single Audit Program (MDSAP)
ISO 13485
Remediation Strategy and Support
Quality System
Technical File and Design History File (DHF)
Data Integrity
Regulatory Action
Manufacturing and Facility Validation
Part 11 and Computerized System Validation
Strategic Consulting
Manufacturing Optimization and Aging Facilities
New Product Development
Product Life Cycle Management
Staffing Support
Mergers and Acquisitions / Due Diligence
Outsourcing DV, CM and MI
Pharmaceutical
Regulatory Affairs
New Product Support
Life Cycle Management
Other Regulatory Services
U.S. Agent Services
Compliance Assurance
Assessments
Audits
Regulatory Agency Response
Preparation, Training, and Inspection Readiness
Quality Assurance
Remediation Strategy and Support
21 CFR Part 210 and 211 Remediation
Regulatory Action
Oversight Services
Data Integrity
Manufacturing and Facility Support
Part 11 and Computerized System Validation
Laboratory Support
Strategic Consulting
Portfolio Management
Manufacturing Optimization and Aging Facilities
Mergers and Acquisitions / Due Diligence
Staffing Support
Change Management
Outsourcing PV, CM and MI
Additional Services
Biologics / BioSimilars
Combination Products
Compounding Pharmacies
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Executive Leadership Team
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Creating Operational Discipline to Support Quality Initiatives
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Compliance Assurance Engagement Leads to Passed FDA Inspection...
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