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Regulatory Specialists, Inc. is a company comprised of regulatory affairs experts in the medical device, diagnostic and pharmaceutical fields. We help assure compliance with FDA and ISO requirements. Our highly skilled regulatory team will bring your organization timely expertise from our valuable knowledge base, and provide indispensable tools to help bring your products to market quickly.
FDA Submissions
- 510(k)'s
- Premarket Notification
- PMA's
- Premarket Approval
- ANDA's
- Abbreviated New Drug Approval
- NDA's
- New Drug Approval
- Medical
Device Listings
- Labeling
Compliance
International System Implementation/Submissions
- MDD/IVDD/AIMDD for European Compliance
- Technical Files
- Design Dossiers
- Import/Export Issues
- Assistance in Coordination and Selection of Notified Bodies for CE Marking
Clinical Studies /Quality Systems
- Regulatory Affairs Compliance
- Quality System Regulations - QSR's
- Good Manufacturing Practices - GMP's
- Quality Manual and Procedure Preparation
- Auditing
- ISO 9000 Registration and Compliance
- ISO 13485 Registration and Compliance
- CMDCAS ISO 13485/Health Canada MDR
- Coordination with ISO Certifying Body
- Software Validations
Clinical
Studies
- Human
Study Coordination
- IRB
Approvals
- Monitoring
- IDE's
- Investigational Device Exemptions
- Statistics
- Data
Auditing
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