Contact Us

CONTACT US

703-966-1100

OUR SERVICES

• Clinical
• Regulatory
• Quality Systems
• Training Solutions
• Compliance
• eCTD
• Expert Witness
• Serialization & Traceability
• Marketing and Distribution
• Inspections - GMP, GCP & GLP
• Listings of Rx, OTC Drugs & Cosmetics

Medical Device Regulations

Do you need help with?
510(k)s
Finding the right Predicate
Classification of your medical device
IDE
PMA
Read more...

FDA Registration and Listings

Do you need to register?
Manufacturers and Remanufactures
Kit Assemblers
Repackagers and Relabelers
Contract Manufacturers and Contract Sterilizers
Specification Developers
Reprocessors of Single Use Devices
Complaint Handlers
Initial Importers
Medical Devices
Cosmetics

Serialization & Traceability

Do you need help with?
Strategic guidance and support services
Our services include program management, regulatory compliance, standards compliance, implementation planning, serialization software vendor selection, trading partner management and integration, validation, troubleshooting, and training.

Healthcare Reimbursement

Do you need help with?

• Healthcare Reimbursement
• Healthcare Policy
• Reimbursement Strategies
• Reimbursement Payment
• Coding/Coverage/Payment
• Medicare Coverage
• Category I &
• Category III CPT Codes
• Payer Relations
• Payor Policy
• Medical Devices

Coding Guidelines for:

• Medicare Billing
• ICD-9 Coding
• CPT
• HCPCS Coding
• C-Code
• APC