Strategic Counsel - 

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

• 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. 

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.