Expert Quality Systems & Regulatory Compliance Solutions
Ensuring Regulatory Excellence Through Expert Quality Systems Leadership
About Us
With over four decades of expertise in quality systems and regulatory compliance, I am committed to delivering tailored solutions that empower pharmaceutical, medical device, and biotechnology organizations to achieve regulatory compliance.
-
![Digital graphic showing a shield with a 'Q' symbol on it interconnected with a balanced scale and legal books, representing quality and justice.]()
Quality Systems & Compliance
Comprehensive quality system assessments and CAPA implementation services.
-
![Digital illustration showing process from cybersecurity shield with tools and gears to a checklist with approval stamp, representing a process of security approval.]()
Regulatory Support
FDA remediation support and regulatory inspection readiness services.
-
![Digital illustration showing a person with a gear and circuitry emerging from a book on the left, leading to certification documents with checkmarks on the right.]()
Training & Development
Custom cGMP/GLP compliance and regulatory readiness training programs.
-
![Flowchart with blue icon of a person and data chart on the left, arrows pointing to a green icon with a clipboard, calendar, trophy, and a checkmark, representing progress and success.]()
Leadership & Project Management
Quality leadership development and project management training services.
-
![Flowchart illustrating a process from analysis to certification, with icons of magnifying glass, gear, document, checklist, and a badge of qualification.]()
Auditing & Assessment
CDMO audits, supplier qualification, and due diligence assessments.
-
![]()
AI Integration & Digital Transformation
AI tool integration and digital transformation for quality systems.
