Regulatory Compliance

Evaluation & Development of Business Strategies within Regulated Environments
• FDA Regulations for Medical Device, Pharmaceutical and Combo Products (21 CFR 820, 210, 211)
• Quality System Regulations (GMP’s)
• ISO 13485 & the European Medical Device Directives
• Canadian Medical Device Regulation
FDA and CE Mark Gap Assessments
Internal and Supplier Auditing
Customer Complaint Handling, Vigilance Systems, & CAPA Investigations
Regulatory Responses to FDA 483, FDA Warning Letters, or Notified Body assessments
Pre and Post Market Clinical Literature Reviews to support Risk Management Programs and European Directives