Glass tower catching golden evening light Regulatory
Affairs Approval, planned and won Gowned technician at work inside a pharmaceutical cleanroom Quality &
Compliance Approval, defended every day after

Our Services

Every Discipline.
One Senior Team.

Specialized consulting services across two practices, each delivered by a leader who has held the seat inside pharmaceutical, biotech, and medical device companies.

Start With the Problem in Front of You.

Nobody engages a consulting firm for "services." You engage one because a submission is due, an inspector is coming, or a program has outgrown the team running it. The map on this page is organized the way those problems arrive: by practice, then by discipline.

Practice One · Regulatory Affairs

Approval, Planned and Won.

Everything between first scientific advice and an approved, launched product: the strategy, the agency relationship, the dossier, and the markets beyond it. Twenty services, each led by someone who has carried a program across this line.

Explore the Regulatory Affairs practice

Strategy & the Agency

8 services
  • Red light trails of night traffic streaming down a highway
    Accelerated Pathways Breakthrough, Fast Track, RMAT, and PRIME, stacked in the right order.
  • Gloved hands comparing laboratory reference-range data sheets
    505(b)(2) Pathway A reliance NDA built on FDA's prior findings and a bridging study.
  • Biosimilar Regulatory Strategy
    Biosimilar Strategy Highly similar biologics via the FDA 351(k) totality-of-evidence route.
  • Marble columns and arches of a neoclassical government building
    FDA Regulatory Consulting End-to-end FDA strategy, from pathway selection to approval.
  • Executives working through a presentation at a boardroom table
    FDA Meeting Strategy Briefing books, rehearsals, and the room itself.
  • International departures board listing cities across the world
    Global Regulatory Strategy One sequencing plan across FDA, EMA, PMDA, and beyond.
  • The empty hemicycle of the European Parliament in Brussels
    European Regulatory Strategy EMA procedures, national routes, and post-Brexit divergence.
  • Analyst overseeing a wall of live data monitors in a control room
    Regulatory Intelligence Monitoring that turns regulatory change into lead time.

Submissions & Dossiers

7 services
  • Stainless steel processing tanks inside a pharmaceutical plant
    CMC Regulatory Affairs Module 3 strategy aligned with what the plant can prove.
  • Writer working through a printed report with pen in hand
    Medical Writing Documents a reviewer can approve, not just read.
  • Close view of a microscope objective over a prepared slide
    Nonclinical Development IND-enabling programs designed to hold up in review.
  • Bound submission volumes stacked in an archive
    eCTD Publishing Sequence-ready publishing that passes first validation.
  • Stacked bound submission volumes in colour-coded covers
    Regulatory Submissions NDA, BLA, 510(k), PMA, and EU filings, engineered for FDA and Europe.
  • Gloved pharmacist holding blister-packed medication
    Regulatory Labeling Core data sheet to country label, kept in lockstep.
  • Wall of labeled catalog drawers in a records room
    Regulatory Operations The tracking, publishing, and archive engine behind every filing.

Products & Markets

7 services
  • An automated clinical analyzer running a diagnostic assay
    Companion Diagnostics The assay and the therapy, co-developed to a single approval date.
  • Sterile surgical instruments laid out on a draped tray
    EU MDR & IVDR Technical documentation and notified-body strategy.
  • Physician annotating a patient report on a clipboard
    Clinical Evaluation Reports CERs that survive notified-body scrutiny.
  • Pharmacist checking stock along shelves of medicines
    Market Access & Reimbursement Approval means little if payers say no. Plan for both.
  • Printed magazine spreads pinned side by side for review
    Advertising & Promo Review Claims that sell without inviting a warning letter.
  • Patient holding an insulin pen injector
    Combination Products Drug, device, or both: one strategy for hybrid products.
  • Magnifying glass resting on the fine print of a document
    Due Diligence & Gap Assessments Know what you are buying, and what an inspector would find.
Where the Practices Meet

Approval Is the Midpoint, Not the Finish.

Regulatory affairs carries a program to the approval letter. The moment it lands, the center of gravity shifts: the quality system becomes the thing regulators come to see. Companies that run the two as one continuous discipline keep their approvals. Companies that run them as separate departments tend to meet us during remediation.

Development Submission Approval Post-Market Regulatory Affairs Leadership Quality & Compliance Leadership
Practice Two · Quality & Compliance

Built to Pass the Audit You Didn't Schedule.

The systems, records, suppliers, and software behind every batch that ships. Twenty services that build, remediate, and defend a quality system, so an unannounced inspector finds a company that was already ready.

Explore the Quality & Compliance practice

Systems & Governance

8 services
  • Compass and drafting tools over an architectural blueprint
    QMS Implementation Quality systems sized to your stage and built to scale.
  • Gowned scientist stepping through a cleanroom airlock
    GxP Compliance GMP, GLP, GCP, GDP, GVP: one coherent compliance posture.
  • Design Controls & Design History File
    Design Controls & DHF Design inputs, V&V, and a Design History File built to pass inspection.
  • Complaint Handling & Medical Device Reporting
    Complaint Handling & MDR Intake to reportability to CAPA, on the MDR and vigilance clock.
  • Row of red procedure binders lined up on a shelf
    SOPs & Document Control Procedures people follow because they were written to be followed.
  • Railway tracks converging at a switch point
    Change Control Every change assessed, justified, and closed on time.
  • Precision caliper measuring a machined metal part
    ISO 13485 & 14971 Certification-ready device QMS and risk files.
  • Climbing harness and carabiners cinched and checked
    Risk Management Risk files that drive decisions, not shelfware.

Inspection & Audit

7 services
  • Sterile glass vials racked in a pharmaceutical facility
    Sterility Assurance EU GMP Annex 1 contamination control strategy, built and defended.
  • Inspector in a hard hat walking a facility with a checklist
    Inspection Readiness Ready for the knock: front room, back room, first hour.
  • Conference table set and waiting for an inspection team
    Mock Inspections The real inspection, rehearsed before it counts.
  • Engineer working at the control panel of production machinery
    CAPA & Remediation Root cause to closed loop, including after a 483.
  • Aerial view of shipping containers stacked at a logistics hub
    Supplier & Vendor Audits Your name is on their deviation. Audit accordingly.
  • Deal team reviewing financial documents together
    M&A Due Diligence Regulatory and quality diligence before the deal signs.
  • Research nurse taking a patient's blood pressure at a clinic visit
    Clinical Quality Assurance GCP oversight from site to sponsor to BIMO.

Data, Technology & Operations

7 services
  • Fingertip pressed to a biometric access scanner
    Data Integrity & Part 11 ALCOA+ evidence for every record an inspector can pull.
  • Validation scripts and system logs across dark monitors
    Computer System Validation CSV to CSA: validation scaled to actual risk.
  • Valves and gauges along an industrial process line
    Commissioning & Qualification DQ to PQ: facilities and utilities proven fit for use.
  • Robotic arm working a station in a modern smart factory
    Digital Transformation Paper to platform without a compliance gap.
  • Robotic hand reaching into a lattice of connected light
    AI & ML Compliance Governance for models regulators are learning to inspect.
  • Capped sample tubes held in frozen storage
    Cell & Gene Therapy Quality Vein-to-vein quality for living products.
  • Operations team monitoring large surveillance displays
    Post-Market Surveillance Signals found by you, not filed against you.
Consultant crossing the atrium of a modern office
How We Deliver

One Team. Three Ways to Engage.

Every service on this page arrives in whichever shape your organization actually needs.

  • Fractional Leadership

    A senior regulatory or quality executive embedded in your team, present in your leadership meetings, for a fraction of the cost of the hire.

  • Project Execution

    A defined deliverable with a single accountable owner: a submission, a remediation, an audit program, a system go-live.

  • Strategic Advisory

    Senior counsel on call for the decisions that shape a program: pathway, positioning, and what to do when the letter arrives.

See How We Work

Every service, delivered inside regulated life sciences

Work With Us

Start With One Service.
Keep the Whole Team.

Tell us the problem in front of you. We'll match you with a senior lead who has solved it before, and respond within one business day. All inquiries are strictly confidential.

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