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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
Compliance Training & Inspection Readiness
Warning Letter Response
Cybersecurity In Medical Devices
Quality Assurance
Data Integrity & cGMP Consulting
Outsourced Quality Support
MDSAP : Medical Device Single Audit Program
ISO 13485
Remediation Strategy and Support
Quality System
Technical File and Design History File (DHF)
Regulatory Response
Manufacturing and Facility Validation
21 CFR Part 11
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
Warning Letter Response
Compliance Training & Inspection Readiness
Quality Assurance
Data Integrity
Good Manufacturing Practices (cGMP)
Manufacturing and Facility Support
Remediation Strategy and Support
Oversight Services
21 CFR Part 11
Regulatory Response
21 CFR Part 210 and 211
Strategic Consulting
Portfolio Management
Pharmaceutical Manufacturing
Mergers and Acquisitions / Due Diligence
Outsourcing & Staff Augmentation
Change Management
Outsourcing PV, CM and MI
Biologics
Lab Testing
Additional Services
Combination Products
Compounding Pharmacies
Regulatory Due Diligence
Expert Witness Services
About Us
Our People
Our Locations
Our Clients
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Executive Consultant Program
Diversity and Inclusion
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Medical Device
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Navigating the Complexities of Name Changes and Re-registration
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FDA Regulatory Pathways for Medical Device
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IVDR Regulation for EU
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505 (b)(2) Pathway
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GMPs for Early Stage Development Projects
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Pharma Product Launch & Lessons Learned
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Animal Testing
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Why Design Control Makes Sense
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