Strategic Leadership
Tactical Execution

Fractional General Counsel for Life Science Companies

Aneta J. Ferguson, JD
Principal Attorney  ·  Orange County, CA
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Profile

Legal Leadership Built for the Life Science Journey

For lean biotech organizations facing increasingly complex milestones, including pivotal trial readouts, public market debuts, or therapeutic launches, legal shouldn't be a hurdle; it should be a strategic launchpad.

I provide Fractional General Counsel services designed for life science companies that need more than just "outside counsel." I offer the business judgment, cross-functional integration, and day-to-day execution of an in-house legal chief without the overhead of a full-time executive or the friction of a big-firm billable hour.

+1.714.271.6991 aneta@lawhealthrx.com LinkedIn vCard

Capabilities

Your Embedded Legal Partner

I provide end-to-end support across the product and corporate lifecycle. I handle the foundational groundwork so your team can focus on the science.

Executive & Board Advisory

  • Fractional GC Leadership: Serving as your "in-house" legal head, providing rapid, business-first decision-making and attending leadership meetings.
  • Board Governance: Managing Corporate Secretary duties, board minutes, and "housekeeping" to ensure public-market readiness.
  • Investor Relations: Supporting the C-Suite in managing relationships with private equity and venture capital partners. I provide the "ground-work" for investor communications and corporate presentations that is vital for maintaining investor confidence and transparency.
  • Public Market Readiness & SEC Oversight: Serving as the central point of integration for your SEC filings (10-Ks, 10-Qs, 8-Ks). I manage the workflow between internal finance teams and specialized outside counsel to ensure disclosures are not only legally compliant but strategically aligned with your corporate narrative.

Clinical & Operations

  • Clinical Trial Infrastructure: Drafting and negotiating global CTAs, CRO agreements, and informed consents to accelerate site activation.
  • Vendor & Contract Management: Architecting streamlined qualification and contracting workflows that eliminate bottlenecks while embedding rigorous risk controls.
  • Data Privacy: Ensuring global operations comply with GDPR, HIPAA, and emerging privacy regulations.

Commercialization & Medical Affairs

  • Launch Readiness: Building the healthcare compliance frameworks (Anti-Kickback, False Claims Act) required for a commercial-ready organization.
  • Review Committee Leadership: Leading Promotional (PRC) and Scientific (SRC) review committees to ensure compliant and impactful communications.
  • Market Access & Patient Support: Advising on market access strategy, copay programs, patient support programs and specialty pharmacy arrangements.

Transactions & Corporate Development

  • Deal Execution: Managing legal workstreams for licensing, M&A, and collaborations, from term sheet to definitive agreement.
  • Data Room & Due Diligence: Building and managing "audit-ready" data rooms to ensure you are always ready for financing, partner or acquirer.
  • IP Integration: Coordinating with outside IP counsel to align the patent portfolio with R&D goals.

Regulatory & Compliance

  • FDA & Regulatory: Harmonizing public and investor disclosures with clinical data and regulatory correspondence to ensure a unified narrative across clinical, regulatory, legal, and investor communications, protecting the company's "deal-ready" valuation.
  • Right-Sized Compliance Programs: Developing and overseeing healthcare compliance frameworks tailored to your company's specific stage, ensuring you meet industry standards without over-engineering processes that hinder agility.
  • Culture of Compliance: Designing and delivering pragmatic training for field teams and HQ that fosters an ethical culture and execution required of "deal-ready" organizations.

Disputes & Emerging Tech

  • Pre-Litigation Dispute & Litigation Management: Providing strategic oversight for early-stage disputes to mitigate risk before escalation. Litigation management support to ensure external counsel remains aligned with your business objectives while controlling costs and maintaining a unified legal strategy.
  • AI Governance & Enablement: Building scalable frameworks for the responsible use of AI across operations. I establish internal policies that mandate IP and confidentiality protections while ensuring data integrity, algorithmic transparency, and compliance with emerging standards. This enables your team to accelerate innovation with a "deal-ready" posture that mitigates long-term regulatory and legal risks.

"Outside counsel is built for specific projects. I am built for the day-to-day life of a biotech company. When you hire me, you aren't just hiring a lawyer; you are hiring a business partner who protects your runway, accelerates your timelines, speaks the language of your Board and investors from Day 1, and understands that 'no' is rarely a helpful answer."

Embedded  ·  Pragmatic  ·  Scalable

Qualifications

Bar Qualification

California

Education

Juris Doctor (JD)
UCLA School of Law
2010
Master of Law
University of Silesia, Poland
2005

Certifications

National Association of Corporate Directors, Directorship Certification
2023
Harvard Law School Executive Education, Women's Leadership Initiative
2022
UCI Paul Merage School of Business, Leadership for Healthcare Management
2021
Harvard Law School Executive Education, Women's Leadership: Adapting and Advocating in a Remote Environment
2021
Privacy Certifications: CIPP/US and CIPP/E
2019
Boston University Certificate, MBA for Lawyers
2017
The Catholic University of America Columbus School of Law, International Business and Trade Law
2005

Practices

Corporate Governance Mergers & Acquisitions Securities Public Company Representation FDA Regulatory Healthcare Regulatory Healthcare Compliance Drug Development & Commercialization Advisory

Industries

Healthcare & Life Sciences Drug Development Technology Startups