Core Concepts
Portfolio Clean-Up
A controlled review and remediation of your FDA device listing records to remove duplicates, retire inactive listings, and correct product code alignment—led by senior regulatory leadership. We treat clean-up as an executive project with defined scope, decision rights, and success criteria, not as ad hoc data entry.
Defensible Traceability
A practical audit trail that captures what changed, when, why, and who approved it—so updates are explainable during FDA inquiries, audits, and commercial due diligence. Leadership receives an inspection-ready record that demonstrates control over the FDA-facing portfolio.
Who Needs This?
- • Manufacturers with long-standing, messy portfolios across multiple sites, brands, and legacy regulatory decisions.
- • Companies post-acquisition or rebranding that have inherited overlapping listings, private-label constructs, or inconsistent naming and product codes.
- • Teams preparing for distributor onboarding, import expansion, or investor / buyer due diligence where a clean FDA footprint is a prerequisite.
What We Deliver
- • Listing inventory and gap analysis across FDA records, internal SKUs, and current commercialization plans.
- • Duplicate removal and controlled deactivation with documented rationale, approvals, and change history.
- • Product code/regulation alignment tied to intended use, risk class, and your current regulatory strategy.
- • Executive summary and risk “heat map” that highlight where clean-up reduces regulatory, audit, and import exposure.
Typical Execution
- ✓ Export & organize inventory into a structured view by establishment, brand, product family, and regulatory pathway.
- ✓ Identify duplicates/inactive records and misalignments, then rank them by regulatory and commercial impact.
- ✓ Rationalize establishments, roles, and relationships (manufacturer, specification developer, repack/relabel, U.S. Agent).
- ✓ Execute controlled updates with agreed approvals and a maintained change log suitable for audits and internal governance.
Roles & Responsibilities (RACI)
Clear accountability for every step of the process.
| Area | Your Team | BRS LLC |
|---|---|---|
| Portfolio Intent | Confirm active products, brands, and SKUs, and align on what “in market” means across functions. | Translate business intent into a prioritized clean-up scope and sequencing, sized to your risk and timelines. |
| Evidence Inputs | Provide labeling and legacy naming context, including private-label, historical constructs, and site roles. | Validate alignment, propose rationalized naming and coding, and document the regulatory rationale for leadership. |
| Execution | Approve deactivations and major changes, especially where commercial, labeling, or supply partners are affected. | Execute updates, maintain the change log, and prepare executive-ready summaries for audits and internal governance. |
| Maintenance | Notify changes via agreed governance (new SKUs, branding changes, site moves, partner changes). | Maintain listings to prevent drift, support scheduled reviews, and keep the FDA-facing footprint inspection-ready. |
Pricing & Coverage Options
Clean-up work is driven by listing count, product mix, and portfolio complexity. We scope transparently so effort, timelines, and decision points are predictable for leadership.
Scan
Identify issues & gaps.
Fixed / Audit
- ✓ Portfolio inventory export.
- ✓ Duplicate/inactive flagging.
- ✓ Priority remediation plan.
Remediate
Execute the clean-up.
Custom / Scope
- ✓ Most Popular for complex portfolios.
- ✓ Controlled updates/deactivations.
- ✓ Product code alignment.
- ✓ Executive-ready change log.
Maintain
Keep it clean.
Annual / Monitor
- ✓ Scheduled portfolio checkups.
- ✓ Change-trigger governance.
- ✓ Audit-ready continuity.
Frequently Asked Questions
What does “portfolio clean-up” mean in practical terms?
It means inventorying your current listings, identifying duplicates and inactive records, correcting misalignments, and documenting controlled updates so your FDA footprint is explainable and stable. You receive an executive summary, detailed inventory, and a simple operating model so the end-state is clear and sustainable.
Why do listings become messy over time?
Common causes include rebranding, site changes, private-label transitions, acquisitions, legacy naming conventions, and ad hoc updates without governance. Over years, each “quick fix” adds complexity until leadership can no longer clearly see what is active, where, and why.
Will clean-up impact my ability to ship product?
Done correctly, it reduces shipment risk by improving accuracy. We phase changes, obtain approvals for any high-impact items, and coordinate timing with commercial and supply chain stakeholders so execution supports, rather than disrupts, product flow.
What’s the difference between “deactivation” and “deletion”?
In practice, clean-up often involves controlled deactivation or retirement of inactive records rather than removing history. The goal is a clean active footprint with explainable history, so you can show regulators and partners what changed and why without losing traceability.
How do you decide which listings should remain active?
We align the FDA-facing portfolio to your active SKUs, current labeling and brands, manufacturing / specification roles, and commercial intent. Decisions are documented and reviewed with your leadership so there is clear agreement on what “active” means going forward.
Can you help confirm product codes and regulation numbers?
Yes. Misaligned product codes are a frequent source of defensibility issues. We support alignment so listings reflect intended use, risk class, and current regulatory pathway, and we document the rationale to support audits and internal governance.
What inputs do you need from us?
A current SKU/portfolio view, any private-label or legacy context, labeling summaries, confirmation of active sites and partners, and clarity on near-term commercial priorities. We keep requests focused so leadership time is used where judgment is needed most.
How long does a clean-up engagement take?
It depends on listing count and complexity. We typically work in phases (Scan → Remediate → Maintain) so you see early improvements while we work through the full portfolio. Timelines are scoped up front so executives understand effort and key decision points.
How do you prevent the portfolio from drifting again?
We implement a straightforward operating rhythm: defined change triggers, approvals, periodic reviews, and a simple change log. The objective is to make the “right way” to update listings the easiest path for your teams, not a one-time clean-up that immediately reverts.
Why choose BRS LLC for portfolio clean-up?
You work with a founder-led, boutique consulting firm that combines senior regulatory judgment with disciplined execution. We bring hands-on FDA device experience, clear communication with executives, and a focus on creating a durable, audit-ready record—not just a one-time spreadsheet.