What Facet Life Sciences does

Facet Life Sciences is a U.S.-based regulatory affairs and product development strategy consultancy founded in 2013 (originally as Virtual Regulatory Solutions, Inc., rebranded in 2014) and headquartered in Wayne, Pennsylvania. The firm serves small and emerging life sciences companies — primarily emerging biotech, small pharmaceutical developers, and medical device innovators — providing integrated advisory services from early preclinical planning through FDA approval, commercialization, and asset divestiture. Its service portfolio spans eight flagship offerings (US Agent Services, Gap Analysis, Strategic Regulatory and Development Guidance, FDA Meeting Consulting, Medical Writing of Submission Documents, Regulatory Submission Leadership, Strategic Statistical Services, and Asset Valuation and Optimization) plus specialty practices in ophthalmology, oncology, PET radiopharmaceuticals, psychedelic therapeutics, and rare/ultra-rare disease innovation.

The firm operates a virtual delivery model with 30+ employees distributed across 14 U.S. states, supported by a curated 20+ partner ecosystem that extends delivery into CMC manufacturing, clinical CRO operations (Lexitas for ophthalmology, Cannovation for psychedelics, Alithia for Australia, Veramed for biometrics), legal and IP, and the KIVO submission management platform (originally Gemstone, internally developed and later spun off as an independent software company). Revenue is generated exclusively through professional services engagements — project-based, retainer, or embedded-team structures — priced via custom scoping of regulatory, CMC, nonclinical, and clinical needs, with no published rate cards. The firm has supported more than 250 companies through FDA formal meetings and 40+ companies through IND/IDE, NDA/BLA, and device submissions.

The company's core technology is its accumulated institutional regulatory expertise rather than a proprietary software platform: proprietary gap analysis frameworks, integrated regulatory strategy methodologies, and 300+ years of combined team experience drawn from FDA-touching organizations (former leaders from Wyeth, Sanofi, Bristol-Myers Squibb, Eli Lilly, and Schering-Plough). Go-to-market is sales-led and consultative, targeting C-suite and executive leadership at small pharma and biotech companies; marketing relies on thought-leadership content (active blog, published Springer reference books, case studies), industry conferences (DIA, RAPS, SNMMI), and community engagement rather than paid acquisition. Distribution is entirely direct, U.S.-focused given the FDA regulatory specialization, with international reach delivered only through partner channels.

Name

Facet Life Sciences

Legal name

Facet Life Sciences

Website

https://facetlifesciences.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

1–10 employees

Short description

Facet Life Sciences is a U.S.-based regulatory affairs and product development strategy consultancy serving small biotech, pharmaceutical, and medical device companies. It provides integrated advisory services spanning gap analysis, FDA meeting preparation, regulatory submissions, statistics, medical writing, and asset valuation, with specialty practices in ophthalmology, oncology, radiopharmaceuticals, psychedelics, and rare diseases.

Ownership category

akta.pro rank

Product category

Regulatory Affairs Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171)

SIC

Services-Management Consulting Services (8742), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

akta.pro secondary industries

Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH), Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)

Keywords

• Regulatory affairs consulting
• FDA submission strategy
• Drug development consulting
• Medical device regulatory
• Biotech regulatory services

Headquarters

HQ city

Wayne

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Consulting and Advisory Services: Facet Life Sciences provides fee-for-service regulatory strategy, gap analysis, FDA meeting preparation, medical writing, regulatory submission leadership, and statistical consulting. Engagement models include project-based consulting, retainer arrangements, and embedded team support. Revenue is generated through professional service engagements billed by the project, hour, or program.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels7 records

Core offering

Facet Life Sciences is a regulatory affairs and product development strategy consulting firm that helps small biotech, emerging pharma, and medical device companies navigate FDA pathways from early development through approval and commercialization. Core engagements span US Agent Services, Gap Analysis, Strategic Regulatory & Development Guidance, FDA Meeting preparation, Medical Writing of regulatory submissions, Regulatory Submission Leadership (IND/IDE/NDA/BLA), Strategic Statistical Services, and Asset Valuation & Optimization, delivered on a project, retainer, or embedded-team basis.

Product overview

Facet Life Sciences is a regulatory affairs and product development strategy partner for small biotech and emerging science companies. The company offers a comprehensive suite of integrated advisory services organized around flagship service pillars: US Agent Services, Gap Analysis, Strategic Regulatory & Development Guidance, FDA Meeting Consulting, Medical Writing of Submission Documents, Regulatory Submission Leadership, Strategic Statistical Services, and Asset Valuation and Optimization. The company also maintains specialty expertise in Ophthalmology, Oncology, PET Radiopharmaceutical Development, Psychedelic Therapeutics, and Rare Disease Innovation Support. Beyond core services, Facet has developed proprietary technology (KIVO submission management platform, formerly Gemstone) and publishes educational content including the FDA and Intellectual Property Strategies for Medical Device Technologies book.

Differentiator

Problem solved

Functional benefit

Products and services

• US Agent Services Liaises with the FDA on behalf of sponsors, serving as an experienced strategic US Agent that facilitates efficient collaboration and leverages decades of successful working relationships with FDA reviewers. Designed for non-US and emerging US companies that require a US-based regulatory point of contact with the FDA.
• Gap Analysis Identifies program gaps, risks, and potential risk mitigation strategies for regulatory submissions across nonclinical, CMC, clinical, regulatory, and tactical dimensions. Used by emerging life sciences companies preparing for FDA meetings, INDs, NDAs, or device submissions.
• Strategic Regulatory & Development Guidance Designs and executes effective regulatory, CMC, nonclinical, and clinical strategies that support end business goals, developing regulatory plans aligned with corporate objectives and resources. Targeted at small life sciences companies needing senior regulatory leadership without an in-house team.
• FDA Meeting Consulting Prepares companies for FDA meetings through rigorous preparation processes, authoring meeting requests, background packages, and coaching to ensure productive interactions with FDA reviewers. Used by sponsors preparing Type A/B/C, pre-IND, EOP, and other formal FDA meetings.
• Medical Writing of Submission Documents Authors and coordinates reviews for regulatory submissions on behalf of sponsors, including planning, preparation, QC, and finalization of documents written with the FDA reviewer in mind. Used by sponsors needing FDA-grade nonclinical, CMC, and clinical submission writing.
• Regulatory Submission Leadership Manages creation, review, and finalization of regulatory submissions for new drug/biologic applications (IND, NDA, BLA), medical device applications, and combination products. Used by small companies needing outsourced regulatory operations leadership for major submissions.
• Strategic Statistical Services Applies advanced statistical principles and methodologies to accelerate development of drugs, biologics, medical devices, and combination products through innovative study designs and cutting-edge analytic techniques. Targeted at sponsors needing expert biostatistics and biometrics support.
• Asset Valuation and Optimization Helps companies know and grow the full potential of their asset at every development stage—from early-stage R&D through commercial launch—spanning market assessment, regulatory alignment, investor support, and pricing strategy. Used by emerging biotech and pharma teams preparing for investor outreach, partnerships, or divestiture.
• Ophthalmic Drug Development Services Expert regulatory and development support for ophthalmology products including dry eye, glaucoma, meibomian gland dysfunction, wet AMD, uveitis, and rare ophthalmic diseases. Targeted at developers of ophthalmic drugs, biologics, devices, and combination products.
• Oncology Drug Development Services

Quantifiable outcome

• Pivotal study database lock to NDA (approved) in six weeks
• +5 more outcomes

Named customers6 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

21 partnerships are on record, tiered core and minor.

• XCancercoreStrategic or Co-development Partner · 6 November 2025Facet Life Sciences and XCancer announced a strategic partnership to accelerate the development and approval of radiopharmaceutical therapies in oncology. The collaboration combines their expertise and infrastructure to streamline clinical trials and expand patient access to precision medicine. The partnership aims to simplify development and regulatory pathways for innovative theranostic therapies.
• Nucleus RadioPharmacoreStrategic or Co-development PartnerNucleus RadioPharma is an end-to-end contract development and manufacturing organization (CDMO) partner dedicated to building robust and reliable clinical and commercial supply chains for targeted radiotherapies. Facet announced Nucleus as an official regulatory partner, providing clinical and commercial supply chain support for radiopharmaceutical programs.
• Alithia Life SciencesminorChannel Partner/ Reseller/ DistributorAlithia Life Sciences is an Australian-owned boutique, full-service CRO launched to support pharmaceutical, biotechnology, device companies, and institutional research groups in the Australian region and beyond. Serves as Facet's regional partner for Australian clinical trial operations.
• CannovationminorChannel Partner/ Reseller/ DistributorA U.S.-based global clinical research organization offering full-service preclinical/clinical research and commercialization services. Specializes in non-traditional cannabinoid and psychedelic-based drugs. Serves as Facet's partner for psychedelic and cannabinoid therapeutic development programs.
• LexitasminorChannel Partner/ Reseller/ DistributorLexitas is a premier CRO dedicated exclusively to ophthalmology since 2011. Provides customized ophthalmic research solutions across all ophthalmology subspecialties. Serves as Facet's ophthalmology-specific clinical operations partner.
• Theranostic TrialscoreStrategic or Co-development PartnerTheranosticTrials.org is the premier global hub advancing cancer Theranostics, connecting every link in the Theranostic Trials Ecosystem. Facet partners with Theranostic Trials to provide regulatory expertise as part of the theranostic clinical trial ecosystem, including for radioligand therapy development.
• Tranquil Clinical ResearchminorChannel Partner/ Reseller/ DistributorTranquil Clinical Research provides clinical trial, device, and drug development process services with ethics and the patient in mind. Serves as Facet's partner for clinical trial execution support.
• TrialwiseminorChannel Partner/ Reseller/ DistributorTrialwise specializes in early phases of drug development, founded in 1999 by Beth Brinsdon. Provides high-level personalized service for start-up and small-to-midsize biotech companies. Serves as Facet's partner for early-phase clinical development.
• IDT AustraliaminorChannel Partner/ Reseller/ DistributorIDT Australia is an ASX-listed Contract Development and Manufacturing Organization (CDMO) based in Melbourne with over 50 years of experience in pharmaceutical manufacturing. Facilities audited by FDA, TGA, and Japanese MHLW. Serves as Facet's Australian manufacturing partner for oral and sterile injectable products.
• RoyalMount Labs (Pharmascience Inc.)minorChannel Partner/ Reseller/ DistributorRoyalMount is a CDMO operating from an FDA-approved site in Candiac, Canada. Capabilities span small molecules, large molecules, oligonucleotides, monoclonal antibodies (mAbs), and antibody-drug conjugates (ADCs). Serves as Facet's Canadian manufacturing partner.
• AsphalionminorChannel Partner/ Reseller/ DistributorAsphalion is a leading regulatory affairs consultancy founded in 2000, providing high-quality services for the development and registration of innovative drugs. Serves as Facet's ex-US regulatory affairs partner for European regulatory support.
• cGMP ValidationminorChannel Partner/ Reseller/ DistributorcGMP Validation is a full-service validation/compliance firm established in 1997 serving pharmaceutical, biotech, biologics, medical device, and diagnostic industries. Provides validation IQ/OQ/PQ protocols and compliance documentation. Serves as Facet's GxP audit partner.
• Troutman Pepper LockeminorOthersTroutman Pepper Locke is a global law firm helping clients solve complex legal challenges in life sciences, including regulatory, intellectual property, and corporate matters. Serves as Facet's legal counsel partner for complex client matters.
• MedSurg PIminorChannel Partner/ Reseller/ DistributorMedSurg PI provides medical affairs services for pharmaceutical, biotechnology, medical device, and related technology companies. Founded and led by experienced clinician-executives with backgrounds in medicine, surgery, technology, product commercialization, and clinical development. Serves as Facet's medical affairs partner.
• Attentive ScienceminorChannel Partner/ Reseller/ DistributorAttentive Science is an FDA-inspected, AAALAC-accredited premier global leader in GLP and non-GLP in-vivo pharmacokinetics, toxicology, and safety pharmacology services. Serves as Facet's nonclinical CRO partner.
• NoscominorChannel Partner/ Reseller/ DistributorNosco is a full-service packaging solutions provider serving 400+ customers in healthcare with over 110 years of experience. Specializes in cartons, labels, inserts, and flexible packaging. Serves as Facet's packaging and printing partner.
• Potomac Law GroupminorOthersPotomac Law is an intellectual property law firm with attorneys across the United States. Serves as Facet's patent support partner.
• Volpe KoenigminorOthersVolpe Koenig is a full-service IP law firm serving U.S. and global clients across varied industries and technologies. Provides strategic intellectual property counseling to protect valuable portfolios and assets. Serves as Facet's additional patent support partner.
• Red NucleusminorChannel Partner/ Reseller/ DistributorRed Nucleus is the premier provider of learning, performance, and process solutions for the life sciences industry with more than 500 full-time employees. Serves as Facet's regulatory publishing and commercial/R&D training partner.
• WAYS Pharmaceutical ServicesminorChannel Partner/ Reseller/ DistributorWAYS Pharmaceutical Services helps biopharmaceutical organizations prepare and submit research documents and supporting data to health authorities worldwide. Serves as Facet's regulatory submission preparation and advisory partner.
• VeramedminorChannel Partner/ Reseller/ DistributorVeramed is a pioneering CRO providing next-level biometrics support across the drug development lifecycle. Certified B Corp providing transparent and collaborative statistical and programming solutions. Serves as Facet's end-to-end biometrics and CDISC/SEND partner.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Pharmalex: Pharmalex is a regulatory and pharmacovigilance consulting firm supporting biotech and pharma companies across FDA/EMA submissions, CMC, and clinical development. Directly comparable to Facet in regulatory services focus and small/mid-cap sponsor client base.
• NAMSA: NAMSA is a medical-device-focused regulatory and testing services firm offering FDA submission strategy, biocompatibility, and clinical trial support. Comparable to Facet in medical device regulatory work, although NAMSA's in-house testing capabilities make it broader.
• NDA Group: NDA Group is a regulatory affairs and product development consulting firm serving pharma and biotech clients with FDA submission and lifecycle strategy services. Highly comparable to Facet in service mix, customer profile (small-to-mid pharma), and consultative selling motion.
• ProPharma Group: ProPharma Group provides regulatory affairs, compliance, and pharmacovigilance consulting to pharma, biotech, and medical device companies. Comparable to Facet in regulatory consulting offerings, mid-market sponsor focus, and project-based engagement model.
• Boyds Regulatory: Boyds Regulatory is a boutique regulatory affairs consultancy offering FDA/EMA submission strategy and clinical development support to biotech clients. Closely comparable to Facet in size, service scope, and emerging-biotech customer profile.

Broad incumbents

• Medpace Holdings: Medpace is a mid-to-large CRO providing full-service clinical development and regulatory services to small and mid-sized biotech sponsors. Comparable to Facet in target customer segment (emerging/small biotech) but broader in clinical operations capability.
• Parexel International: Parexel is a global CRO with a large regulatory affairs consulting practice serving biotech and large pharma across the full development lifecycle. Overlaps with Facet in regulatory strategy and submission services but operates at much greater scale and across multiple geographies.
• IQVIA: IQVIA is the world's largest CRO with regulatory consulting, real-world evidence, and clinical development services. Overlaps with Facet in regulatory strategy for pharma/biotech but at vastly greater scale and with broader technology and analytics capabilities.
• Charles River Laboratories: Charles River Laboratories is a CRO/CDMO offering regulatory and development services alongside nonclinical and manufacturing capabilities. Overlaps with Facet in regulatory strategy and FDA submission support, particularly for combination and biologic products.
• ICON plc: ICON plc is a global CRO offering regulatory consulting, clinical operations, and laboratory services across all major therapeutic areas. Comparable to Facet in regulatory consulting offerings but at substantially larger scale and global reach.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/facetls
• Xx.com/Facet_LS

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds

Investors

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

M&A

Investments1 record

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

Frequently asked questions about Facet Life Sciences