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Services

Expert assistance and solutions for technical regulatory compliance, focused on medical devices, infection control and pharma products.

Regulatory Agency Compliance

 

U.S. FDA:
Premarket Notification preparation- 510(k)
Premarket Notification 510(k) Exemptions
Premarket Approval Applications (PMA)
Labeling/Claims Compliance Review
Establishment Registration
Device Listing
U.S. FDA Agent

Canada CMDR:
Device Classification
Device Licensing
Licenses Exemption
Establishment Registration & Licensing

European Union MDD-CE:
ISO 13485 Compliance
Device Classification
Technical File preparation
NB Review
CE Certification and Marking

Australian TGA:
Establishment Registration
Product Registration

Compliance Action Planning:
FD483 Observation Management
Warning Letters
Consent Decree
Recall Management

Electromechanical Device Compliance:
IEC 60601-X

 

cGMP and Directives Compliance

 

Design Control Compliance:
Design Input/Output preparation
Documentation Systems – Design History File (DHF)
Outside Observer

Risk Assessment and Management:
ISO14971 Compliance

Process Qualification & Validation:
IQ /OQ /PQ

Packaging Qualification & Validation:
ISO 11607

Compliance Auditing:
FDA Quality System Regulation (QSR)
ISO 13485
Canada Medical Device Regulation

Training:
Compliance
QSR-cGMP
Sterilization
Microbiology
Root Cause Analysis
Audit Preparedness

Microbiology, Sterilization & Laboratory Services

 

Microbiological Testing:
Bioburden
Particulate Analysis
Sterility Testing
Disinfection Efficacy
Microbial Limits
BI Certification
Cytotoxicity
Sterility Resistance
Strategic Alliance with Certified ISO 13485 Laboratory

Sterilization:
Radiation, e-beam, ETO, Steam
Process Validation – ISO 11137
VHP
Novel Processes

Biological Evaluation:
ISO 10993

Expiration Dating:
Accelerated Aging Studies
Real Time Aging Analysis
Simulated Transportation Testing
Packaging Qualification & Validation: ISO 11607

Management Strategies

 

Operational Effectiveness Programs:
S.W.O.T.
Capabilities Alignment
Quality Statistics Generation
KPI Management
Lean Process Design
Intellectual Property Strategies
U.S. CMS-HCPCS Reimbursement Analysis and Strategies