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Medical Device
Regulatory Affairs
New Product Approval Support
Post Approval Support
Other Regulatory Services
EU Medical Device Regulation (MDR)
Compliance Assurance
Assessments
Audits
Preparation and Training
Regulatory Agency Response
Cybersecurity In Medical Devices
Quality Assurance
Data Integrity & cGMP Consulting
Outsourced Quality Support
Medical Device Single Audit Program (MDSAP)
ISO 13485
Remediation Strategy and Support
Quality System
Technical File and Design History File (DHF)
Regulatory Action
Manufacturing and Facility Validation
Part 11 and Computerized System Validation
Strategic Consulting
Manufacturing Optimization and Aging Facilities
New Product Development
Product Management
Outsourcing & Staff Augmentation
Mergers and Acquisitions / Due Diligence
Outsourcing DV, CM and MI
Pharmaceutical
Regulatory Affairs
New Product Support
Product Lifecycle
Other Regulatory Services
Compliance Assurance
Assessments
Audits
Regulatory Agency Response
Preparation, Training, and Inspection Readiness
Quality Assurance
Data Integrity
Good Manufacturing Practices (cGMP)
Manufacturing and Facility Support
Remediation Strategy and Support
Oversight Services
Part 11 and Computerized System Validation
Regulatory Action
21 CFR Part 210 and 211 Remediation
Strategic Consulting
Portfolio Management
Pharmaceutical Manufacturing and Aging Facilities
Mergers and Acquisitions / Due Diligence
Outsourcing & Staff Augmentation
Change Management
Outsourcing PV, CM and MI
Biologics
Lab Testing
Additional Services
Combination Products
Compounding Pharmacies
Private Equity Due Diligence
Legal Services
About Us
Our People
Our Locations
Our Clients
We are 100% Client Focused
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Remediation and Compliance within New FDA Regulatory Framework
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Developing a Quality System on a Managed Budget
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Compliance Audit Leads to Passed FDA Inspection
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Manufacturing Automation for Medical Devices
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FDA Data Quality Warning Letter
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Process Validation Remediation
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Product Cleaning Endotoxin Control
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Regulatory 510(k) Analysis Development Product Cleaning / Disinfection
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