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Quality & Regulatory Compliance Corporation

Pharmaceutical & Medical Device Regulatory Compliance

 

Providing consulting services to the pharmaceutical and medical device industry

 

 

Contact

☎ CONTACT

qrccorporation@gmail.com
+1 (224) 595-4178

 

Areas of Practice


Quality Systems implementation

  • New quality management systems from the ground up and upgrades of existing systems
  • Lean documentation strategies

quality system audits

  • Regulatory compliance mock audits
  • Internal audits
  • Supplier audits
  • Third party audits
  • Variable-scope process audits

regulatory compliance

Remediation and compliance turnaround;

  • Warning letter responses and corrective action implementation strategies
  • FDA form 483 responses and strategies to fulfill commitments
  • Compliance correspondence and meeting support with regulatory agencies

investigations and CApa support

  • Non-conformity management systems
  • Complaint management systems
  • CAPA implementation and project management

quality systems training

  • FDA GMP
  • FDA QSR
  • ISO 13485

international quality systems

  • EU
  • US
 
 

Let's Talk.

Use the form below to contact us. Please be as detailed as possible. You may also email or call us to make an appointment.