5091 Lawler Avenue
Fremont, CA  94536
Phone: 510-894-4162

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Services

Pre-clinical support for Good Laboratory Practices (GLP) and non-GLP studies

• Protocol development
• Data collection
• Report writing
• Study Director project management activities

Product development support using FDA and ISO guidelines for compliance to the Quality System regulations including

• Failure Mode and Effect Criticality Analysis (FMECA)
• Budget preparation and management
• Protocol and informed consent development
• Investigator recruitment and contract negotiation
• Institutional Review Boards and Ethics Committee (IRB/EC) submissions
• Data collection form design (case report) for protocol and database design
   integration
• Data review, analysis and medical report writing
• Training/presentations for study and regulatory requirements, site coordination
   and management

Clinical study support for all phases (pre-approval and post-approval) ensuring compliance to applicable US and international requirements

Clinical and regulatory support incorporating US and international requirements

• Procedures and guidelines development and implementation

Regulatory applications and reports

• Pre-market notifications - 510(k)
• Pre-market Approvals (PMA)
• Investigational Device Exemptions (IDE)
• Certificate of Conformity (CE) dossiers
• Medical Device Reports (MDR)
• Vigilance reports
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