Embedded in Your Team.
Put senior regulatory and quality leadership behind your next critical milestone.
Experience Across the Life Sciences
Senior-level regulatory and quality expertise, embedded in your team.
FDA, EMA, and global regulatory strategy across pharma, biotech, and medical devices, led by people who have sat across the table from the agencies.
Talk to a Regulatory Expert
Ready before the inspector arrives
Quality systems that satisfy regulators and protect patients: built, remediated, and proven inside real operations, not on paper.
Talk to a Quality ExpertWhether you need ongoing embedded leadership, a defined project delivered, or strategic advisory support: we have a model that fits where you are.
Monthly retainer
Your de facto Head of Regulatory or Quality.
A senior expert integrates directly into your team, owning strategy, leading submissions, engaging regulators, and building your function while you scale.
Fixed scope · Fixed fee
A defined outcome, scoped and delivered.
Specific deliverables executed end-to-end by a senior consultant. Every engagement opens with a scoping phase that locks deliverables, timeline, and price before any work begins.
On-demand
Senior counsel, exactly when it counts.
On-demand regulatory and quality counsel for the decisions that carry the most weight — strategy reviews, agency meeting prep, diligence, and board-level briefings.
Whichever model fits, the work is led by a senior practitioner with direct experience at FDA, Big Pharma, and global life sciences organizations — never junior consultants or project managers.
Our consultants bring direct experience in the disease areas your products address, not just the regulatory frameworks around them.
Expert perspectives on the evolving regulatory landscape, written by senior practitioners who work in it every day.
The Monthly Briefing
One email a month for pharma, biotech, and device leaders: what changed, why it matters, and what to do about it. Written by the consultant who does this work for clients, not a content team.
One email a month. No sales sequence. Unsubscribe anytime.
Written personally by Connor Griggs, Founder & Managing Principal
A representative sample of engagements delivered by our consultants
across pharmaceutical, biotech, medical device, IVD, and combination product programs.
Three years as FDA and EU MDR regulatory lead for thirty supplier-transfer cost-improvement projects across the orthopaedics portfolio. Owned regulatory impact assessments, Tech File updates, labeling remediation, and reporting to the executive team.
Led all regulatory and quality deliverables across six in-vitro diagnostic product launches, including innovative diabetes management systems and blood analyzers. Built the Risk Management File for each and drove ISO 13485:2016 QMS implementation across the organization.
Brought in after the Quality Manager exited weeks before the ISO 13485 notified body audit. Closed open CAPAs, remediated ISO 14971 gaps, executed an internal audit, and supported the organization through the audit itself.
Led the implementation of the Global Unique Device Identification Database (GUDID) and managed regulatory document preparation and submission across multiple regions. Kept device data airtight and compliant while supporting post-market activities that carried products to approval and market readiness.
Owned regulatory documentation and post-market compliance for US Class II and III devices. Converted legacy technical files to the Summary Technical Documentation (STED) format, streamlining the documentation system, and kept it inspection-ready through disciplined CAPA responses.
Supported FDA's technical review of live 510(k) and PMA submissions, researching and evaluating sponsor dossiers alongside agency reviewers. That reviewer's-eye view of what earns questions — and what earns clearance — now shapes every submission we build.
Regulatory Leadership Partners is a specialized life sciences consulting firm that deploys senior regulatory and quality experts as embedded fractional leaders. We serve pharmaceutical, biotech, medical device, IVD, cell and gene therapy, and digital health organizations at every stage of the product lifecycle — from first regulatory strategy through post-market compliance.
Work With Us
We needed someone who could walk into FDA and speak the same language — and that’s exactly what we got. The work was done at a level I’d expect from someone who’s been doing this for 25 years.
— VP of Regulatory Affairs, Top-10 Medical Device Manufacturer
