Catalyst Healthcare Consulting

Name

Catalyst Healthcare Consulting

Legal name

Catalyst Healthcare Consulting Inc.

Website

https://catalysthcc.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

1–10 employees

Ownership category

akta.pro rank

Product category

Healthcare Regulatory Consulting

NAICS

Management Consulting Services (54161), Administrative Management and General Management Consulting Services (541611)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Strategy & Corporate Development Consulting (BPAHACAA)

akta.pro secondary industry

Public Sector & Policy Consulting (BPAHACAN)

Keywords

• Regulatory affairs consulting
• Healthcare policy advisory
• FDA regulatory strategy
• Cell and gene therapy consulting
• Market access consulting

Headquarters

HQ city

Mclean

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Marketing or Sales, Operations, Technology or R&D, Others

Revenue model

1. Regulatory Policy Consulting Services: Professional consulting services providing regulatory policy development, strategic regulatory affairs support, FDA engagement strategy, and policy consensus building for healthcare innovators across the cell and gene therapy, pharmaceutical, digital health, and medical device sectors.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Catalyst Healthcare Consulting is a regulatory policy and regulatory affairs consulting firm that provides strategic advisory services to healthcare innovators. Its offering spans FDA regulatory pathway strategy, science communications, market and regulatory intelligence scans, reimbursement and access strategy, cross-functional strategic vision development, industry consensus building, network expansion, and nascent technology barrier clearance. The firm operates a hub-and-spoke model that pairs a small core team with an extended network of former regulators, scientists, patient advocates, and healthcare strategists engaged on a per-project basis.

Product overview

Catalyst Healthcare Consulting is a regulatory policy and regulatory affairs consulting firm that provides strategic advisory services to healthcare innovators. The company offers a portfolio of consulting capabilities rather than a unified software product or platform. Services include regulatory submissions and pathway strategies, science communications, market scans and regulatory intelligence, reimbursement and access strategy, cross-functional strategic vision development, industry consensus building, network expansion, and nascent technology barrier clearance. The firm serves biopharmaceutical companies, cell and gene therapy developers, digital health companies, medical device companies, trade associations, patient advocacy groups, venture capital firms, and academic institutions across the healthcare ecosystem.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Policy and FDA Strategy Consulting Strategic advisory on FDA regulatory pathways, policy development, and agency engagement for biopharmaceutical, cell and gene therapy, digital health, and medical device innovators seeking to bring novel therapeutics to patients.
• Reimbursement and Market Access Strategy Advisory on coverage strategy, reimbursement pathway development, payer engagement, and Medicaid policy for healthcare innovators translating regulatory approvals into patient access.
• Cell and Gene Therapy Regulatory Policy Consulting Specialized regulatory policy advisory for cell and gene therapy developers, including clinical trial design input, long-term follow-up optimization, FDA engagement, and consensus building with regulators, industry, and patient communities.
• Science Communications and Research Support Science writing, regulatory policy research, and stakeholder messaging support for clients needing to translate complex scientific and regulatory content for expert and lay audiences.
• Industry Consensus Building and White Paper Convening Multistakeholder facilitation, working groups, and white paper production that bring together patient advocates, industry, academia, and government to align on regulatory and policy positions such as CAR T-cell long-term follow-up optimization.
• Regulatory Intelligence and Horizon Scanning Industry-based horizon scans and regulatory intelligence reports identifying top emerging cell and gene therapy technologies and policy developments likely to impact the industry, patients, and regulatory thinking over a 3-10 year horizon.
• Startup and Emerging Innovator Advisory Strategic advisory for healthcare startups and emerging coalitions of innovators, including regulatory pathway planning, FDA engagement, reimbursement readiness, and network expansion across the healthcare ecosystem.
• FDA Workshop and Public Meeting Convening Co-hosting and facilitation of FDA public workshops, listening meetings, and stakeholder convenings on topics such as pediatric cell and gene therapy clinical trials and CBER knowledge leveraging.

Quantifiable outcome

• Successfully helped resolve clinical trial delays for cutting-edge cell and gene therapy company within weeks of engagement
• +2 more outcomes

Named customers6 records

Segments7 records

Ideal customer profiles6 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

17 partnerships are on record, tiered core.

• Alliance for Regenerative MedicinecoreStrategic or Co-development Partner · 9 April 2026Co-hosting the FDA CBER OTP and ARM joint workshop 'Advancing Pediatric Cell and Gene Therapy Clinical Trials' on April 9, 2026 at FDA Headquarters. ARM is a major trade association representing the cell and gene therapy industry.
• Friends of Cancer ResearchcoreStrategic or Co-development Partner · 8 August 2025Multistakeholder collaboration led by Catalyst to recommend data-informed optimization of CAR T-cell therapy long-term follow-up. Partners included patient advocacy groups, academia, industry, and government organizations working to reduce LTFU requirements from 15 to 5 years.
• Leukemia & Lymphoma SocietycoreStrategic or Co-development Partner · 8 August 2025Partner in multistakeholder collaboration on CAR T-cell therapy long-term follow-up optimization white paper, contributing patient advocacy perspective to consensus building efforts.
• University of PennsylvaniacoreStrategic or Co-development Partner · 8 August 2025Academic research partner contributing scientific expertise to CAR T-cell therapy LTFU optimization white paper, including research on timing of adverse events.
• Kite PharmacoreStrategic or Co-development Partner · 8 August 2025Industry partner in multistakeholder CAR T-cell therapy LTFU optimization collaboration, contributing commercial perspective on long-term follow-up processes.
• Bristol Myers SquibbcoreStrategic or Co-development Partner · 8 August 2025Industry partner contributing to CAR T-cell therapy LTFU optimization white paper, representing pharmaceutical perspective on clinical trial and commercial LTFU requirements.
• Johnson & JohnsoncoreStrategic or Co-development Partner · 8 August 2025Industry partner in multistakeholder collaboration on CAR T-cell therapy long-term follow-up optimization research.
• Novartis PharmaceuticalscoreStrategic or Co-development Partner · 8 August 2025Industry partner contributing to CAR T-cell therapy LTFU optimization white paper collaboration.
• National Institutes of HealthcoreStrategic or Co-development Partner · 8 August 2025Government partner contributing to CAR T-cell therapy LTFU optimization research, including expertise on NIH research priorities and public health impact.
• A2 BiotherapeuticscoreStrategic or Co-development Partner · 8 August 2025Biotechnology company partner in multistakeholder collaboration on CAR T-cell therapy long-term follow-up optimization.
• Artiva BiotherapeuticscoreStrategic or Co-development Partner · 8 August 2025Biotechnology company partner contributing to CAR T-cell therapy LTFU optimization white paper research.
• Emily Whitehead FoundationcoreStrategic or Co-development Partner · 16 December 2024Catalyst partnered with the Emily Whitehead Foundation to survey nearly 100 patients and caregivers about their perspectives on CAR T-cell therapy long-term follow-up experiences. The collaboration produced the white paper 'Amplifying the Voice of CAR T-Cell Therapy Patients and Caregivers' highlighting the urgent need for patient-centered LTFU processes.
• FDA CBER OTPcoreStrategic or Co-development PartnerCatalyst CEO Nancy Myers participated in FDA CBER Office of Therapeutic Products public listening meeting, presenting a framework for CBER to better leverage existing knowledge across sponsors, external partners, and the broader health ecosystem.
• Friends of Cancer ResearchcoreStrategic or Co-development PartnerDr. Jeff Allen, President and CEO of Friends of Cancer Research, participated as panelist in Catalyst-led DIA 2025 session on accelerating cell and gene therapy trials through innovative Master Protocol designs.
• University of PennsylvaniacoreStrategic or Co-development PartnerDr. Kiran Musunuru, Professor of Medicine at University of Pennsylvania, joined Catalyst's DIA 2025 panel on CGT umbrella trials. His ground-breaking work on 'Baby KJ' treatment paved the way for FDA-endorsed umbrella/platform trial frameworks.
• NIH Division of Rare Diseases Research InnovationcoreStrategic or Co-development PartnerDr. PJ Brooks, Deputy Director of NIH Division of Rare Diseases Research Innovation, served as panelist in Catalyst's DIA 2025 discussion on streamlining GT development platforms and umbrella trials.
• Alliance for Regenerative MedicinecoreStrategic or Co-development PartnerARM commissioned Catalyst Healthcare Consulting to conduct a comprehensive industry-based horizon scan identifying top emerging C&GT technologies poised to impact the industry, patient lives, and regulatory thinking in the next 3-10 years.

Scale indicators2 records

Recent moves6 records

Expansion highlights5 records

Market position

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/catalyst-healthcare-consulting-inc-
• Xx.com/Catalyst_HC_C

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds1 record

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Catalyst Healthcare Consulting