Strategic Counsel -

Operations Excellence

Combination Products Strategy & Compliance

Integrated regulatory, quality, and usability guidance for products that bridge drug, device, and biologic pathways.

Regulatory pathway strategy for drug–device–biologic combinations, including 21 CFR Part 4 alignment and global regulatory mapping.
Request for designation (RFD). Bridging strategies connecting device design controls (21 CFR 820/ISO 13485) with drug/biologic quality system and CMC expectations
Primary mode of action (PMOA) assessments and support for Office of Combination Products (OCP) requests, interactions, and designation confirmations
Human factors and usability engineering integration across development, validation, and submission packages
Transfer of regulatory obligations throughout the product lifecycle including agreements, risk management, post-market safety reporting, and change control regulatory impact assessments
Technical documentation preparation, including combination product sections for IND, NDA/BLA, 510(k)/PMA, and EU MDR/IVDR files

Whether you’re navigating complex post-approval requirements, preparing for high-impact regulatory meetings, pursuing expedited pathways, or entertaining potential label expansion claims we deliver the focused regulatory expertise needed to keep progress uninterrupted. Every package is built to meet expectations, reduce uncertainty, and support timely approvals.

Regulatory Strategy

Targeted regulatory expertise for complex, high-stakes, or time-sensitive initiatives across the product lifecycle. We provide the specialized capabilities that keep programs compliant, current, and progressing without disruption.

Lifecycle management and post-approval change control including CMC variations, annual reports, and global maintenance submissions
Safety and vigilance support (FDA, EMA, MHRA) including adverse event reporting, signal assessment, and periodic safety updates (PSUR/PBRER)
Global renewals and re-registrations ensuring uninterrupted market presence across jurisdictions
Request for Regulatory designation (RFD) and expedited program support including Orphan Drug, Breakthrough Therapy, Fast Track, PRIME, and other accelerated pathways
Regulatory body | Health Authority (FDA/EMA) meeting preparation and management: briefing package development, question strategy, meeting rehearsal, and post-meeting action plans
Regulatory procedure development including SOPs, work instructions, internal training, and governance frameworks aligned with current global expectations
Extension of label claims/ Supplemental applications (sNDA) supporting the full range of post-approval supplements—including labeling updates, CMC changes, safety revisions, and new indications. We deliver the specialized regulatory execution that keeps your program moving forward with precision and confidence

With deep cross-functional expertise across QA, RA, and complex lifecycle execution, we bridge strategy and delivery—helping teams move from uncertainty to decisive, compliant action.

Whether you’re advancing a combination product, navigating high-stakes regulatory submissions, or managing global post-market obligations, we bring the structured thinking, hands-on support, and senior-level insight needed to keep your program on track.

Our approach is practical, anticipatory, and grounded in real-world industry experience—so you don’t just meet regulatory expectations, you stay ahead of them.

Expert guidance to restore compliance, rebuild trust, and strengthen long-term operational resilience.

When organizations receive FDA 483 observations, Warning Letters, or face the pressures of a Consent Decree, the path to remediation requires more than corrective action—it demands clarity, discipline, and an experienced hand that understands both the letter and the spirit of global regulatory expectations.

My regulatory remediation support provides organizations with structured, actionable, and sustainable pathways back to compliance, ensuring that remediation efforts not only resolve current gaps but also fortify the systems, culture, and practices that prevent recurrence.

Regulatory Remediation Services Include

Immediate response strategy and roadmap development to triage critical gaps, prioritize risk, and communicate transparently with regulators.
Root-cause analysis and CAPA strengthening grounded in systems thinking, human factors, and operational realities.
Quality system rebuilds or redesigns to ensure the organization emerges stronger, more compliant, and more resilient than before.
Documentation remediation and narrative restructuring to align evidence with regulatory expectations and support inspection readiness.
Execution oversight and governance support to ensure commitments are met and progress is measurable, auditable, and regulator-ready.
Culture and behavior reinforcement to ensure changes “stick” rather than degrade under operational pressures.

This is not check-the-box remediation—it's a holistic, disciplined, and forward-looking partnership designed to restore compliance, rebuild confidence, and elevate performance long after the remediation is complete.

If you want, I can also tailor this to match the length or tone of your other service descriptions, or create a shorter web-optimized version.

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