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About ADBCCRO
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Clinical Research Organization
Clinical Trial Design
Site Selection and Management
Protocol Development
Regulatory Submissions for Clinical Trials
Data Management and Analysis
Clinical Study Reports
Post-Market Surveillance
Product Development Services
Design Controls and Risk Management
Prototyping and Feasibility Studies
Human Factors Engineering
Design History File (DHF) Compilation
Product Labeling Development
Packaging Design and Validation
Quality Service
Gap Assessment
Quality Audit
FDA 483 Response and Remediation
Customs Holds on Products
Product Recall Management
QMS Development from Scratch
GMP Certification Preparation
MDSAP Preparation
ISO 13485 Certification Preparation
CAPA Implementation
Internal Audit Training and Execution
Supplier Quality Management
Regulatory Services
US Agent Services
Pre Submission Support
513(g) Request for Classification
510(k) Submission Preparation
PMA Submission
De Novo Classification Requests
IDE Submission
Regulatory Strategy Development
FDA Meeting Prep & Representation
Labeling and Advertising Compliance
MedDev Listing & Registration
Regulatory Risk Assessment
Cybersecurity Solutions
HIPAA Compliance Assessments
Data Security for Medical Device
Cyber Risk Assessments
Incident Response Planning
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