FDC Service
FDC Services provides executive consulting services to the medical products industries, specializing in global regulatory compliance, clinical/regulatory affairs, and quality systems. Established in 2001, they assist companies in achieving approvals, handling clinical studies, improving quality systems compliance, and navigating FDA requirements. Their services include international regulatory affairs, compliance, project management, and sterilization science, among others.
Industries
Nr. of Employees
small (1-50)
FDC Service
Austin, Texas, United States, North America
Products
Executive Consulting Services
Consulting services specializing in Global Regulatory Compliance, Clinical/Regulatory Affairs, and Quality Systems for the Medical Products Industries.
Executive Consulting Services
Consulting services specializing in Global Regulatory Compliance, Clinical/Regulatory Affairs, and Quality Systems for the Medical Products Industries.
Services
Consulting and preparation support for domestic and international regulatory submissions for medical products.
Protocol development, site initiations, monitoring, clinical summaries, and oversight of contract research organizations.
Design and implementation of ISO 13485 and QSR-compliant quality systems, internal audits, CAPA programs, and regulatory training.
Validation and technical consulting for sterilization methods including aseptic fill processes and multiple sterilization technologies.
Design consulting for clean room and laboratory facilities to support regulated manufacturing and testing.
Management of recalls and field actions, including health hazard evaluation, regulatory notification, remedial actions, and recall tracking.
Consulting and preparation support for domestic and international regulatory submissions for medical products.
Protocol development, site initiations, monitoring, clinical summaries, and oversight of contract research organizations.
Design and implementation of ISO 13485 and QSR-compliant quality systems, internal audits, CAPA programs, and regulatory training.
Validation and technical consulting for sterilization methods including aseptic fill processes and multiple sterilization technologies.
Design consulting for clean room and laboratory facilities to support regulated manufacturing and testing.
Management of recalls and field actions, including health hazard evaluation, regulatory notification, remedial actions, and recall tracking.
Expertise Areas
- Clinical trial management
- Global regulatory compliance (US and international)
- Quality systems and ISO 13485 / QSR compliance
- Sterilization science and validation
Key Technologies
- Regulatory submission preparation (510(k), PMA, IDE)
- Clinical monitoring and protocol development
- Quality management systems (ISO 13485, QSR, CAPA)
- Post-market vigilance and MDR systems