TradeStone QA
Regulatory quality assurance and consulting firm offering mock regulatory (BIMO) and cGMP audits, quality systems reviews, and compliance support for clinical research organizations, institutional review boards, medical device sponsors, and pharmaceutical manufacturers. Services include inspection preparedness, data management and 21 CFR Part 11 assessments, validation review, postmarket surveillance support, and employee training.
Industries
Nr. of Employees
small (1-50)
TradeStone QA
Products
Bubble Gum Badge: An FDA His-Story (book)
A book discussing the U.S. Food and Drug Administration's role in public health oversight and reflections on areas for improvement.
Mock Regulatory
Mock regulatory CGMP manufacturing and Quality Assurance inspections for contract manufacturing organizations, innovators, and generic drug companies.
Mock regulatory audits
Simulated regulatory audits designed to test and improve organizational readiness for official inspections.
Employee training
Specialized employee training programs including offerings eligible for continuing education units (CEUs).
API & sterile Drug Product pharmaceutical cGMP mock FDA audits
Mock cGMP audits specifically tailored for active pharmaceutical ingredients and sterile drug product manufacturing facilities.
Aseptic Pharmaceutical Manufacturing Mock FDA, Quality Systems and cGMP Inspections
Specialized mock inspections focusing on aseptic pharmaceutical manufacturing, quality systems, and cGMP compliance.
Bubble Gum Badge: An FDA His-Story (book)
A book discussing the U.S. Food and Drug Administration's role in public health oversight and reflections on areas for improvement.
Mock Regulatory
Mock regulatory CGMP manufacturing and Quality Assurance inspections for contract manufacturing organizations, innovators, and generic drug companies.
Mock regulatory audits
Simulated regulatory audits designed to test and improve organizational readiness for official inspections.
Employee training
Specialized employee training programs including offerings eligible for continuing education units (CEUs).
API & sterile Drug Product pharmaceutical cGMP mock FDA audits
Mock cGMP audits specifically tailored for active pharmaceutical ingredients and sterile drug product manufacturing facilities.
Aseptic Pharmaceutical Manufacturing Mock FDA, Quality Systems and cGMP Inspections
Specialized mock inspections focusing on aseptic pharmaceutical manufacturing, quality systems, and cGMP compliance.
Services
Simulated inspections of clinical sites, manufacturing facilities, and sterile pharmacies to evaluate regulatory readiness and identify compliance gaps.
Audits of electronic data systems and controls to evaluate compliance with electronic records and signature requirements.
Review of validation documentation and strategies for laboratory and manufacturing systems.
Assistance with adverse event surveillance programs and regulatory reporting for marketed products.
On-site or remote audits to qualify component suppliers and product vendors for manufacturing operations.
Training workshops and continuing education for staff on quality systems, inspection preparedness, and regulatory expectations.
Simulated inspections of clinical sites, manufacturing facilities, and sterile pharmacies to evaluate regulatory readiness and identify compliance gaps.
Audits of electronic data systems and controls to evaluate compliance with electronic records and signature requirements.
Review of validation documentation and strategies for laboratory and manufacturing systems.
Assistance with adverse event surveillance programs and regulatory reporting for marketed products.
On-site or remote audits to qualify component suppliers and product vendors for manufacturing operations.
Training workshops and continuing education for staff on quality systems, inspection preparedness, and regulatory expectations.
Expertise Areas
- Inspection readiness and mock BIMO audits
- cGMP manufacturing quality assurance
- Medical device quality systems and MDR/MDR-like reporting
- Postmarket surveillance and adverse event reporting
Key Technologies
- cGMP inspection methodologies
- Quality System Inspection Technique (QSIT)
- 21 CFR Part 11 electronic records/electronic signatures assessment
- Aseptic processing and sterile manufacturing practices