AREAS OF EXPERTISE

CONSULTING & AUDITING


FDA-RCA™ supports organizations in the detection, correction, and prevention of regulatory compliance issues during the manufacturing and laboratory operations of pharmaceuticals, medical device and biotechnology products.

FDA-RCA™ offers a full range of consulting and auditing services conducted by Ms. Rodríguez, Industry Advisor and former FDA National Expert Investigator / Former FDA National Lead Instructor.

  • BIOTECH

  • PARENTERALS
  • ​​STERILITY
  • ​PROCESS
    VALIDATION

  • ​​CLEANING
    VALIDATION

  • ​STABILITY
  • ​​DATA
    INTEGRITY

  • ​CSV/PART 11
  • ​FDA AUDITS
  • ​​FDA WARNING
    LETTERS

  • Response to FDA-483s
  • Response to FDA Warning Letters
  • Failure Investigations, Root-Cause-Analysis (RCA) and Problem-Solving Techniques
  • Evaluation and implementation of Corrective and Preventive Action Plans (CAPA)
  • Laboratory and Manufacturing cGMP Controls
  • Process Validation
  • Vendor audits
  • Gap assessment of manufacturing/laboratory validation and execution of protocols
  • Assessment of Technical Transfer and Analytical/Bioanalytical Test Methods
  • FDA Audits of Microbiological Laboratories
  • NDA/ANDA Pre-Approval drug manufacturer inspections for all dosage forms including combination products
  • Biotechnology Manufacturing and Laboratory Operations
  • GMP and FDA Inspection techniques geared towards Drug, Biotech and Medical Device manufacturers
  • Data Integrity in Laboratory and Manufacturing Operations
  • Computer System Validation (CSV)
  • Electronic Records; Electronic Signatures (21 CFR Part 11)
  • Process Analytical Technology (PAT)
  • Cleaning Validation Program
  • Stability Program
  • Regulatory Submissions, NDAs and ANDAs 
  • Pre-Operational Reviews of Facilities

FDA Regulatory Compliance Advisors, Inc.

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