“Combining science with regulatory knowledge for optimized systemic solutions.” ™ 

FDA Regulatory Compliance Advisors, Inc.™

SPECIALIZED SERVICES

FDA Warning Letters can expose organizations to negative publicity, delay approvals, damage to reputation and brand name, risk loss of business and customers, and higher-level sanctions.

To prevent an FDA Warning Letter, organizations have to ensure that there is a compliant quality system in place including comprehensive knowledge about regulations that govern the quality and safety requirements relevant to their products.  

FDA-RCA™ helps organizations establish robust quality and compliance management programs in the following specialized areas:

• QUALITY
  POLICIES
  

• ​COMPLAINTS
  

• ​OOS
  
• ​LIAISON WITH
  FDA OFFICES
  
• ​​ANNUAL GMP
  TRAINING
  
• QbD
  
• ​​PAT
  
• ​EMERGING
  TECHNOLOGY
  

SPECIALIZED

AREAS

• Provide support for FDA GMP and Pre-Approval inspection readiness
• How to audit like an FDA Auditor: A combination of consulting, auditing and training program, including “Train-the-Trainer”
• Annual GMP training for Drug, Biotech and Medical Device manufacturers
• Data Integrity in Manufacturing and Laboratory Operations
• Evaluation, response and commitments to FDA Warning Letters
• Evaluation of regulatory risk and criticality of non-conformances, deviations, complaints, manufacturing investigations, and OOS reports      from an FDA perspective
• Development of Quality Policies for Manufacturing and Laboratory Operations
• Support management with formal communication with FDA Field and Headquarter Offices
• Gap assessments of Environmental Monitoring and Cleaning Validation programs for aseptic and non-sterile manufacturing facilities
• Evaluation and recommendations for Emerging Technologies
• Provide support for Quality by Design (QbD), Process Analytical Technology (PAT) and Continuous Manufacturing projects

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