FDC Services LLC International Regulatory Affairs Compliance & Quality Systems
			Services Available
			FDC Services Include: US and International Medical Device Regulatory Affairs; including 510(k)'s, PMA's, IDE's and CE marking.  Submission assistance  for Canada, Australia, Japan, Korea, Taiwan, China, and Europe. FDA Liaison; FDA pre-submission strategy meetings, Panel and Committee meetings, Official Correspondent, US Agent Services, management representative Drug and Device Regulatory and cGMP Compliance; Compliance Audits, Training, Management Assistance Recalls and Field Action Activities; Public Affairs, Health Hazard Evaluation, FDA notification requirements, Remedial Actions, Management of Recall tracking and notifications. Adverse Events, Complaint, MDR, and Vigilance Reporting Systems; Training and Department Set-up Quality Systems; ISO 13485 and QSIT Compliant Quality Systems, Quality Manuals, Internal Audit, CAPA Project Management, Development; Resource and cost estimation and allocation, Management of Timelines and Deliverables CE Marking, Technical Files, Design Dossiers; Work with European Notified Bodies and Competent Authorities, Declarations of Conformity, Risk Analysis, Essential Requirements Clinical Affairs; Site Initiations, Clinical Monitoring, Protocol Development Due Diligence; New Business Development and Acquisition Evaluations.  Potential Business Partner and Supplier Audits Sterilization Technology and Validation Services, Including Aseptic Fill Technology, Ethylene Oxide, Steam, Dry Heat, Ozone, Sterrad, and Radiation Clean Room and Lab Design CGMP Training Interim/Acting QA RA or Compliance Management Representation at Technical Committees and Industry Associations FDC Services is affiliated with several other quality consulting firms so if we can't help you, we probably know someone who can.  Please contact us for assistance.