TM

“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