Life Sciences Compliance & Legal

Your outside compliance
and legal team, without
the overhead.

We embed with pharma and biotech companies as a fractional extension of your leadership. The expertise of big law and a seasoned CCO, structured for the way early-stage companies actually work.

Schedule a ConsultationOur Services
CLIENT LEGAL SAVINGS
$650K+
Reduced outside counsel spend
REVIEW CYCLE TIME
55%
Faster PRC review cycles
COMPLIANCE PROGRAMS
Day One Ready
Full programs, ready for inspection
$650K
In legal savings in year 1 for one client
38%
Average reduction in outside counsel costs
Day One Ready
Full compliance programs, ready for inspection
55%
Faster PRC review cycles on average
20+
Years pharma & biotech experience
What We Do
Four practices, one team. A seamless extension of your organization.
Fractional Compliance Officer
A full compliance infrastructure: program builds, policy suites, monitoring plans, training, committee leadership, and government reporting. All without a full-time hire.
Add Verigage, our AI-assisted compliance platform for HCP engagements, to replace email-and-spreadsheet workflows with a structured system that significantly cuts review time to minutes and produces an audit trail you'd be happy to hand OIG.
Compliance Program DesignChief Compliance OfficersPolicies & SOPsTrainingRisk AssessmentsInternal Audit & MonitoringInvestigations and EnforcementCAPAs
Life Sciences Legal
Contract review and negotiation for vendor agreements, speaker agreements, clinical trial agreements, and CDAs. Outside general counsel services at a fraction of the cost of big law.
Commercial AgreementsResearch and Development AgreementsFractional General CounselCorporate Governance
Fair Market Value Advisory
Fair market value assessments for HCP engagements. Custom tiering methodologies, rate cards grounded in published survey data, and audit-defensible documentation.
FMV Methodologies & Rate CardsFMV AssessmentsFederal Exclusion and Debarment ScreeningsAudit Prep
Ad Promo Review
Legal and regulatory review of promotional materials against the PI, FDA guidance, and OPDP enforcement. PRC/MLR process design, platform selection, and committee staffing.
Legal ReviewersRegulatory ReviewersMedical ReviewersCoordinatorsPRC/MRC Process DesignPlatform Evaluation

Built for the companies that are changing medicine.

NorthStar Advisors works with pre-commercial and early-commercial pharma and biotech companies that need experienced compliance and legal support without the overhead of a full-time hire.

If you're approaching PDUFA, launching your first commercial product, or building out your compliance infrastructure, we operate as a fractional extension of your team: embedded in your day-to-day, available when you need us, and structured to scale with you through commercial launch and beyond.

Typical Engagements
  • Compliance program build for a company preparing for its first commercial launch
  • Outside GC support through clinical-stage milestones
  • FMV program design ahead of a first advisory board or speaker program
  • PRC/MLR buildout and staffing for a growing promotional review function
Dan Zavodnick
Dan Zavodnick
Founder & Principal

20+ years helping pharma and biotech companies get it right.

Dan Zavodnick founded NorthStar Advisors to give pre-commercial and early-commercial life sciences companies the kind of compliance and legal leadership that typically comes only with a full-time hire or the rates of big law, neither of which makes sense at the earliest stages.

Before NorthStar, Dan spent over two decades in pharma and biotech compliance and legal roles, building programs from the ground up, leading PRC/MLR functions, negotiating complex HCP and vendor agreements, and advising executive teams through product launches, government investigations, and rapid growth.

He works as a fractional CCO and outside general counsel, embedding directly with client teams, not as a distant advisor but as a working member of the leadership bench.

LinkedIn Profile Get in Touch

Let's start a conversation.

Whether you're standing up a compliance program, navigating a complex contract, or preparing for your first advisory board.

Schedule a Consultation
Emaildan@navigatewithnorthstar.com
Mobile347-541-9747
LinkedInDan Zavodnick