Propel-Q
Accelerate cGxP Compliance
Expert Biopharma Consulting - Leveraging 25+ years of Quality and Regulatory Leadership
About
Propel-Q LLC
I'm the founder and principal consultant of Propel-Q LLC, a specialized consultancy dedicated to helping biopharmaceutical and medical device companies achieve and maintain cGxP compliance excellence. With over 25 years of leadership experience in Quality and Regulatory functions, I partner directly with organizations to optimize compliance strategies, remediate issues, and drive operational effectiveness.
I offer comprehensive cGMP consulting services tailored to your organization's specific needs—whether you require interim leadership, proactive compliance preparation, or regulatory remediation support. My expertise ensures your firm is audit-ready and positioned for long-term success in a dynamic regulatory landscape.
Throughout my career, I've scaled quality organizations from startup ventures to global networks encompassing 23 sites and approximately 1,200 colleagues. I'm known for defining corporate quality standards, driving inspection readiness, and leading regulatory engagements with international authorities, including the FDA, EMA, MHRA, Health Canada, Swissmedic, and ANVISA.
My broad product expertise spans AAV gene therapies, biologics, small molecules, APIs, combination products, and medical devices—including sustained release injectables, inhalation therapies, topical biologics, and Class I–III devices.
At Propel-Q, I am committed to being your trusted partner in navigating the evolving compliance landscape, safeguarding your regulatory standing, and enhancing your operational resilience..
Services
Strategic Insights
Operational Effectiveness & Governance System Assessments: Evaluating and enhancing your quality systems and governance structures for optimal performance.
Leadership & Organizational Reviews: Analyzing organizational structures and leadership effectiveness to drive continuous improvement.
Interim Head of Quality Leadership: Providing temporary leadership to guide your quality organization through transitions or challenges
Proactive Compliance
QMS Development & Optimization: Designing and refining Quality Management Systems to align with regulatory requirements and industry best practices.
IND/BLA Preparation & Submission Support: Assisting in the preparation and submission of Investigational New Drug (IND) applications and Biologics License Applications (BLA).
GMP & QMS Gap Assessments: Identifying and addressing gaps in Good Manufacturing Practice (GMP) compliance and Quality Management Systems.
GMP Vendor Audits & Qualifications: Conducting audits and qualifications of vendors to ensure compliance with GMP standards.
Mock Inspection Readiness & Internal Audits: Preparing for Pre-Approval Inspections (PAI) through mock audits and internal assessments
Compliance Remediation
FDA 483 & Warning Letter Responses: Developing effective responses to FDA observations and warning letters to address compliance issues.
Consent Decree Support & Follow-Up: Providing guidance and support in navigating consent decrees and ensuring ongoing compliance.
For-Cause Audits & Investigations: Conducting thorough audits and investigations in response to specific compliance concerns.
QMS Repair & Risk Mitigation: Implementing corrective actions and risk mitigation strategies to restore and enhance Quality Management Systems
Schedule your appointment
Let's Collaborate on Your Compliance Goals.
Schedule a consultation today to discuss how we can navigate your compliance challenges together and drive your business forward.
