SSI Strategy
- Company typePrivate
- Founded2011
- HeadquartersParsippany, United States
- Headcount101–250
- GTM typeB2B
- OfferingServices
SSI Strategy firmographics
Firmographics- Name
- SSI Strategy
- Legal name
- SSI Strategy LLC
- Website
- https://ssistrategy.com
- Company type
- Private
- Founded year
- 2011
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Ownership category
- akta.pro rank
Where SSI Strategy is headquartered
LocationHeadquarters
- HQ city
- Parsippany
- HQ country
- United States
- HQ region
- North America
Offices5 records
Markets served
SSI Strategy business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure
Revenue model
- Strategic Consulting Services: SSI Strategy generates revenue through fee-for-service consulting engagements with biotech clients. Services span the drug development lifecycle including strategic medical office, translational & clinical development, clinical operations, evidence & value, medical affairs, program management & governance, quality & compliance, regulatory affairs, safety & PV, and high-stakes FDA/EMA meetings. Revenue is project-based and retainer-oriented, reflecting a professional services model.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom consulting engagements — no standardized tiers publicly disclosed |
Go-to-market motion1 record
Distribution channels3 records
Marketing channels8 records
SSI Strategy product offering
Product offeringCore offering
SSI Strategy is a strategic consulting firm that embeds seasoned executives, clinicians, regulatory experts, and operators directly into biotech and biopharma organizations. It delivers multidisciplinary advisory services across the drug development lifecycle — from pre-clinical and translational strategy through clinical operations, regulatory affairs, evidence generation, medical affairs, safety/pharmacovigilance, quality and compliance, to high-stakes FDA/EMA meeting preparation and commercialization readiness.
Product overview
SSI Strategy is a strategic consulting firm for biotech innovators offering multidisciplinary consulting services across the drug development lifecycle from preclinical through commercialization. The core offering consists of integrated consulting service modules including The Strategic Medical Office, Translational & Clinical Development, Clinical Operations, Evidence & Value, Medical Affairs, Program Management & Governance, Quality & Compliance, Regulatory Affairs, Safety & PV, and High-Stakes Meetings support. These services are delivered through bespoke teams of regulatory experts, clinicians, safety professionals, and business consultants embedded directly into client organizations. Supporting content platforms include The Emerging Biotech Leader Podcast and Regulatory: The Emerging C-Suite Leader Podcast. Advisory services include the Executive Advisory Network (connecting clients with active biotech leaders) and the NDA Advisory Board for regulatory strategy support.
Differentiator
Problem solved
Functional benefit
Products and services
- The Strategic Medical Office Strategic medical office consulting service ensuring scientific integrity and patient advocacy through strategic alignment and stakeholder engagement for biotech organizations.
- Translational & Clinical Development Clinical development consulting service that innovates life-changing therapies through patient-centric clinical development, transforming assets and organizations into clinical-stage entities.
- Clinical Operations Clinical operations consulting service empowering sponsors with strategic leadership and operational excellence in clinical trial execution.
- Evidence & Value Evidence and value consulting service unlocking therapy's full potential with strategic evidence generation, health economics, and real-world evidence for regulatory approval and payer acceptance.
- Medical Affairs Medical affairs consulting service transforming medical affairs into a strategic driver for success, supporting medical organization design and launch readiness.
- Program Management & Governance Program management and governance consulting navigating complexity with strategic oversight and cross-functional collaboration for drug development programs.
- Quality & Compliance Quality and compliance consulting service accelerating success through strategic quality and compliance consulting, including inspection readiness and QMS gap assessments.
- Regulatory Affairs Regulatory affairs consulting service providing regulatory strategy and leadership for drug development, including NDA advisory board support and EU regulatory submissions.
- Safety & PV Safety and pharmacovigilance consulting service safeguarding patient well-being through strategic risk management and operational excellence in pharmacovigilance.
- High-Stakes Meetings High-stakes meetings consulting service driving success in pivotal FDA and EMA interactions, helping clients prepare for critical regulatory meetings.
- Executive Advisory Network Curated advisory network of active biotech and biopharma Board Members, CEOs, and CMOs providing independent, non-salaried strategic counsel to SSI clients at pivotal inflection points, including former executives from Novartis, Roche, Merck, and GSK.
- NDA Advisory Board Strategic advisory service providing regulatory expertise and guidance for NDA preparation and submission processes.
- Embedded Executive Services Bespoke embedded service model placing teams of regulatory experts, clinicians, safety professionals, and business consultants as an extension of client organizations, including Board Member, CEO, CMO, and Functional Leader placements.
Quantifiable outcome
- SSI Strategy has served over 280 biopharma companies across U.S. and European markets since 2010.
- +3 more outcomes
Companies that use SSI Strategy
Customer profileNamed customers4 records
Segments2 records
Ideal customer profiles2 records
SSI Strategy technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature2 records
SSI Strategy partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- Clinigen GroupcoreClinigen Group, a global pharmaceutical services company focused on improving patient access to medicines, entered into a definitive agreement to acquire SSI Strategy in September 2025. The acquisition combines SSI's strategic depth, established U.S. and European footprint, and pioneering partnership models with Clinigen's global operational reach in clinical trial supply, managed access, and commercialisation. The deal adds 200 employees (including 145 expert consultants) and a client base of over 280 biopharma companies to Clinigen's Lifecycle Services offering. The transaction was expected to close before end of 2025, subject to customary closing conditions. SSI continues to operate as SSI Strategy under current leadership (CEO Doug Locke) post-close.
- Fiore Healthcare AdvisorscoreSSI Strategy announced the acquisition of Fiore Healthcare Advisors, a long-term partner and life sciences consultancy, in June 2021. Fiore Healthcare Advisors had been scaled by founder Greg Fiore, MD (who co-founded SSI Strategy in 2011) to nearly $10 million in annual revenues before its acquisition. The deal brought additional pharmacovigilance and medical affairs expertise to SSI's service portfolio. Amit Patel, former President of Fiore Healthcare Advisors, joined SSI Strategy as SVP to lead the Pharmacovigilance Services Hub.
Scale indicators7 records
Recent moves5 records
Expansion highlights6 records
SSI Strategy competitors and assessment
Company assessmentDirect peers
- Trinity Partners: A life sciences-focused strategy consulting firm serving biotech and pharmaceutical clients across commercial, R&D, and medical affairs. Closely comparable to SSI in its biotech specialization, project-based delivery model, and therapeutic-area depth.
- Putnam Associates: Biopharma strategy consulting firm focused on commercial strategy, market access, and evidence generation. Comparable to SSI's Evidence & Value and Medical Affairs service lines and its emerging/mid-stage biotech client base.
- Lumanity: Life sciences consulting firm specializing in medical affairs, evidence generation, HEOR, and value strategy. Direct overlap with SSI's Medical Affairs, Evidence & Value, and Strategic Medical Office offerings.
- Defined Health: Biotech strategy consulting firm advising emerging therapeutic companies on clinical development, regulatory, and commercial strategy. Directly comparable in client segment and strategic advisory focus.
- PharmApprove: Regulatory and FDA/EMA meeting preparation consultancy. Closely comparable to SSI's High-Stakes Meetings and Regulatory Affairs service modules, and counts SSI's SVP Laurie Smaldone Alsup among its alumni.
- NDA Group: Regulatory affairs consultancy with deep NDA submission expertise and an advisory board offering. Directly comparable to SSI's NDA Advisory Board and Regulatory Affairs practices.
- Alacrita Consulting: Biotech-focused consulting firm providing strategy, due diligence, and commercial advisory to emerging biotechs. Highly comparable to SSI's emerging-biotech focus and therapeutic-area expertise.
Broad incumbents
- IQVIA: Global CRO and life sciences consulting powerhouse with deep R&D, real-world evidence, and strategic advisory capabilities. Competes with SSI for biotech consulting work and counts SSI's CFO Craig Ungaro among its former healthcare leadership.
- Charles River Associates: Global consulting firm with a Life Sciences practice providing strategic and economic advice to biopharma and medtech clients. Overlaps with SSI on regulatory strategy, evidence generation, and commercial launch advisory.
- Huron Consulting Group: Large diversified professional services firm with a significant life sciences practice spanning R&D, regulatory, and clinical operations. Competes with SSI for biotech consulting engagements and counts SSI's SVP Leah Damesek among its alumni.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
SSI Strategy social profiles
Digital presenceSSI Strategy compliance and trust
Trust signalCompliance1 record
SSI Strategy financial estimates
Financial estimateRevenue estimate
Valuation estimate
SSI Strategy leadership team
Management profileNumber of profiles
Profiles9 records
SSI Strategy subsidiaries and ownership
Company hierarchySubsidiaries1 record
SSI Strategy funding detail
Funding detailFunding overview
Funding rounds2 records
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
SSI Strategy M&A and investment
M&A and investmentM&A1 record
Investments2 records
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about SSI Strategy
What does SSI Strategy do?
SSI Strategy is a strategic consulting firm that embeds seasoned executives, clinicians, regulatory experts, and operators directly into biotech and biopharma organizations. It delivers multidisciplinary advisory services across the drug development lifecycle — from pre-clinical and translational strategy through clinical operations, regulatory affairs, evidence generation, medical affairs, safety/pharmacovigilance, quality and compliance, to high-stakes FDA/EMA meeting preparation and commercialization readiness.
Is SSI Strategy a public or private company?
SSI Strategy is a private company. It is classified as private equity controlled and is currently operating.
When was SSI Strategy founded?
SSI Strategy was founded in 2011. It employs 101 to 250 people.
Where is SSI Strategy based?
SSI Strategy is headquartered in Parsippany, United States, in the North America region.
How does SSI Strategy make money?
One revenue line is on record: strategic Consulting Services.
Who are SSI Strategy's main competitors?
Direct peers on record are Trinity Partners, Putnam Associates, Lumanity, Defined Health, PharmApprove, NDA Group and Alacrita Consulting. Broad incumbents are IQVIA, Charles River Associates and Huron Consulting Group.
Does SSI Strategy have an API?
No public API is recorded for SSI Strategy.