Vicky C. Stoakes, President

IntegRx, Inc. is an FDA Compliance Consulting firm based in Atlanta, GA. Our team is led by Vicky Stoakes, a former FDA Investigator with over 30 years of combined consulting, FDA, and pharmaceutical industry experience. Our network of consultants includes former FDA and industry experts, dedicated to helping clients with their pharmaceutical and biopharmaceutical GMP consulting needs and offering proficiency in regulatory and compliance services.

Clients praise IntegRx for our professional expertise, technical competence, and constructive interactions with employees, suppliers, and third-party contractors. We specialize in Mock FDA Pre-Approval Inspections, GMP compliance audits, FDA inspection readiness, and remediation strategy development. Additionally, we offer custom training and education programs to help keep your staff informed about the latest regulatory requirements. Our commitment to excellence and client satisfaction has earned us a reputation as a trusted partner in the pharmaceutical industry.

We work with both domestic and international clients, from small start-ups to established global corporations, helping them navigate the complexities of FDA regulations. Whether you require a simulated FDA inspection or an external perspective on a specific issue, IntegRx delivers tailored solutions to support your organization's unique needs.

Professional Services

NDA /ANDA/ NADA / ANADA / BLA Mock FDA Pre-Approval Inspections, cGMP Audits, Due Diligence Assessments, and RiskMAP / REMS Compliance Audits
Advising Pharmaceutical and Biopharmaceutical Executives on critical compliance deficiencies, risk mitigation strategies, remediation plans, and FDA expectations
Consultation on FDA regulatory and compliance issues
Development of strategies for FDA Inspection preparation and readiness, remediation, and compliance improvement
Assistance in composing written responses to FDA Inspections and Regulatory Actions
Liaison and coordination on client's behalf with FDA District Offices and Centers
Development and presentation of customized training on various topics to meet the individual needs of each client, including FDA Pre-Approval Inspection Readiness and Annual cGMP Training

Expertise

Professional Services

Sterile and Non-sterile Dosage Forms and Active Pharmaceutical Ingredients (APIs)
Quality Systems
Facilities
Containment
Bioburden Control
Environmental Monitoring
Chemistry and Microbiology Laboratories
Data Integrity
Stability Programs
Validation and Qualification
Materials Management
Packaging
Labeling