Cerneos

What Cerneos does

Cerneos Group, LLC is a life sciences consulting firm founded in 2012 and headquartered in Newton, Massachusetts. The firm provides integrated regulatory affairs, scientific development, and business services to clients across the biotech, medical device, diagnostic, and pharmaceutical sectors. Its primary offerings include global regulatory strategy and submission development (INDs, BLAs, NDAs, 510(k), PMA, DeNovo), clinical trial and CRO coordination, CMC documentation, quality system implementation (GxP, GLP, GMP, ISO 13485, ICH), validation and qualification programs, validation/qualification services, and grant proposal writing for agencies such as NIH, NSF, DoD, BARDA, DARPA, and NASA. The firm also provides business services including team development, project management, fundraising support, strategic partnerships, global supply chain coordination, and soft-landing services for international innovators entering U.S. markets.

Cerneos's competitive positioning rests on a senior consulting team whose members collectively bring 20+ years of experience from major pharmaceutical companies (Pfizer, Merck, Novartis, Grifols), medical device firms (Intuitive Surgical, Varian, Terumo, Sanmina-SCI), and government agencies (NIH/NIAID, US Navy). CEO and founder Richard C. Tharin holds an RAC certification and has led more than 100 successful regulatory submissions across multiple international health authorities including FDA, Health Canada, MHRA, ANVISA, PMDA, CFDA, KFDA, EMEA, and NHS. Senior consultant Richard Reeves brings experience from Varian Medical Systems, Intuitive Surgical, and Sanmina-SCI with participation in 100+ regulatory audits. The firm's cumulative regulatory milestones include 20+ INDs, 30+ BLAs, 25+ Pre-IND meetings, 150+ Medical Device 510(k)s, and 75+ diagnostic IVDs and NDAs. Named clients include Insulet Corporation, Novartis, Pfizer, Merck, Kimberly-Clark, American Red Cross, Grifols, NIH/NIAID, Intuitive Surgical, Varian Medical Systems, and Long Island University.

The business operates on a project-based professional services model with quote-based, customized pricing. Customer acquisition is sales-led, leveraging industry events (BIO International Convention, Aging Code and Pitchfest), strategic partnerships with associations such as MassMEDIC, RAPS, and MassBio, plus referral channels. Cerneos has added adjacent capabilities in 2025 including Telemedicine Solutions, Microfluidic Assay Development, and a STEAM Art collaboration ecosystem launched in December 2025. The firm remains privately held, founder-controlled, with no disclosed institutional investors, funding rounds, or acquisitions.

Name

Cerneos

Legal name

Cerneos Group, LLC

Website

https://cerneos.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

11–50 employees

Short description

Cerneos Group is a Newton, Massachusetts-based life sciences consulting firm providing regulatory affairs, scientific development, quality systems, and business services to biotech, medical device, diagnostic, and pharmaceutical clients globally. Founded in 2012, the firm helps clients navigate FDA and international health authority submission processes.

Ownership category

akta.pro rank

Product category

Regulatory Affairs Consulting

NAICS

Management Consulting Services (54161), Management, Scientific, and Technical Consulting Services (5416), Other Scientific and Technical Consulting Services (54169)

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 Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Clinical Trials Authorization & Oversight (GCP) (HLAJADAF)

Keywords

• Regulatory affairs consulting
• Clinical trial coordination
• Medical device submissions
• Pharmaceutical regulatory strategy
• Quality system compliance

Headquarters

HQ city

Newton

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory & Clinical Consulting Services: Professional consulting services for global regulatory strategy, submission development, and clinical trial coordination for biotech, device, diagnostic, and pharma products. Revenue generated through project-based engagements with clients ranging from startups to large pharmaceutical firms.
2. Scientific & Engineering Development Services: Scientific research feasibility studies, pre-clinical safety evaluations, technical and CMC documentation, and grant proposal writing services. Revenue generated through specialized consulting engagements for product development and regulatory submissions.
3. Business Services: Team development, project management, financing and fundraising support, strategic partnerships, global supply chain support, and soft landing services. Revenue generated through advisory and consulting engagements for startups and established life science firms.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels9 records

Core offering

Cerneos Group, LLC is a consulting firm that provides integrated regulatory, scientific, and business development services to life science companies. Their offerings span global regulatory strategy and submission development (INDs, BLAs, NDAs, 510(k), IVD, MDR/IVDR), clinical trial coordination with international health authorities, scientific/CMC documentation and pre-clinical safety evaluations, quality system implementation and validation programs, and strategic business services including fundraising, grant proposal writing, and soft-landing support for innovators.

Product overview

Cerneos Group is a consulting services firm offering integrated product development solutions for the life sciences industry. Their portfolio consists of three primary service pillars: Regulatory & Clinical Trial/Evaluation Services, Scientific & Engineering Development Services, and Business Services. These service lines encompass specialized offerings including regulatory submissions management (IND, ANDA, BLA, 510(k)), quality system and compliance solutions (GXP, GLP, GMP, ISO 13485), validation and qualification programs, strategic business development, and grant proposal development. The company positions itself as an integrated team that develops basic assets and technologies into commercially viable products through science, finance, and strategic partnering alliances.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory & Clinical Trial/Evaluation Services Global regulatory strategy, submission development, and clinical trial coordination for biotech, device, diagnostic, and pharma products, working with international health authorities such as FDA, Health Canada, MHRA, ANVISA, PMDA, CFDA, and KFDA.
• Scientific & Engineering Development Services Scientific research feasibility studies, pre-clinical safety evaluations, technical and CMC documentation for design, patent, and regulatory submissions, and grant proposal writing for agencies like NIH, NSF, DoD, BARDA, DARPA, and NASA, as well as human factors and usability evaluations.
• Business Services Team development, project management, resource acquisition, financing and fundraising support for startups and established firms, strategic partnerships, global supply chain support, U.S. agency coordination for international life science and med-tech firms, soft landing services for innovators in multiple regions, Medicare reimbursement planning, business market analysis, and NIH/SBA/DoD/NSF grant funding support.
• Quality System and Compliance Solutions Quality manuals and quality systems implementation, Quality Suite Development (GXP, GLP, GMP, QSR, ISO 13485, ICH), internal and supplier audits (Compliance, CE Mark, CAPA verifications, MDSAP), and MDSAP and Remote Auditing systems for compliance.
• Validation and Qualification Programs Process validations (Sterility, Aseptic Processing, Fill/Finish operations), cleanroom, HVAC and Temperature Control System Validations, equipment validation and qualification (IQ, OQ, PQ), and software validation.
• Regulatory Submissions Management IND, ANDA and BLA submissions for small molecule and biologic products, CMC preparation for BLA and NDA projects, regulatory submissions management with FDA, and Briefing Book development for Type A, B, C meetings with FDA.
• Fundraising and Grant Proposal Development Fundraising and grant proposal development for early stage biotech, medical software and medical device ventures, including grant proposals for vaccine therapeutics.
• Microfluidic Assay Development Microfluidic assay development for remote blood testing.
• Telemedicine Solutions Telemedicine solutions for home exams.

Quantifiable outcome

• 20+ INDs led
• +5 more outcomes

Named customers11 records

Segments6 records

Ideal customer profiles3 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 minor and core.

• SCI-X StudiominorStrategic or Co-development PartnerPartner listed on Cerneos partnerships page. Nature of collaboration involves integrated project delivery.
• Montero Language ServicesminorStrategic or Co-development PartnerLanguage services partner for international regulatory submissions and documentation needs.
• ONIXminorStrategic or Co-development PartnerPartner listed on Cerneos partnerships page for integrated project delivery.
• Ambrosia VenturesminorStrategic or Co-development PartnerStrategic partner providing integrated solutions for life science ventures.
• Clinically MediaminorGTM or Marketing PartnerMarketing partner that built the Cerneos website. Ongoing marketing collaboration.
• The Idyeas GroupminorStrategic or Co-development PartnerPartner listed on Cerneos partnerships page for integrated project delivery.
• Evergreen Bioscience Innovation ClustercoreStrategic or Co-development PartnerActive collaboration on education and mentoring programs for bioscience innovators. Cerneos supports Evergreen Bioscience Innovation programs.
• Beyond the PhDminorStrategic or Co-development PartnerPartner providing career development resources for PhD professionals in life sciences.
• MassMEDICcoreGTM or Marketing PartnerNetworking organization member providing industry connections and community for medical device companies in Massachusetts region.
• RAPS (Regulatory Affairs Professionals Society)coreStrategic or Co-development PartnerActive member in good standing. Cerneos abides by RAPS Code of Ethics. Key credential and networking organization for regulatory professionals.
• BIO International ConventioncoreGTM or Marketing PartnerAnnual conference participation for networking, client acquisition, and industry visibility. Major industry event for biotech and life sciences.
• MassBiocoreGTM or Marketing PartnerNetworking organization member providing industry connections for Massachusetts biotech and life sciences companies.
• ITC (IandI D'Orio)minorStrategic or Co-development PartnerIntellectual property legal services partner for patent and trademark support.
• Mao Miyamoto Medical Media Inc.minorStrategic or Co-development PartnerSTEAM Art collaborator for science-art partnerships, medical illustration, and educational content creation.
• Enlight VisualsminorStrategic or Co-development PartnerSTEAM Art collaborator for science-art partnerships and visual content creation.
• BioTools InnovatorminorStrategic or Co-development PartnerCerneos participated as judge for BioTools Innovator Road Show evaluating research tools for life science industry entrepreneurs.
• One NucleuscoreStrategic or Co-development PartnerCerneos has acted as mentor, judge, and networking partner for One Nucleus over 2 years to support biotech innovation worldwide.

Scale indicators8 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• NAMSA: NAMSA is a medical-device focused CRO offering regulatory, clinical, and testing services. Cerneos competes directly for the same medical device regulatory submission and quality systems engagements, particularly on 510(k) and MDR/IVDR work.
• Proxima Clinical Research: Proxima is a boutique CRO providing regulatory affairs, clinical trial, and quality consulting to medical device and pharma companies. It mirrors Cerneos' focus on early-phase regulatory strategy and submission support for similar client profiles.
• Biologics Consulting Group: Biologics Consulting Group is a regulatory and product development consultancy serving biologics, vaccine, and gene therapy sponsors. It overlaps with Cerneos on BLA/IND support, CMC documentation, and FDA meeting preparation work.
• Rho: Rho is a CRO focused on regulatory strategy, biostatistics, and clinical development for emerging pharma and biotech. It serves a similar mid-market client base that needs regulatory submission support and CMC/clinical coordination.
• RJR & Co Regulatory Affairs Consulting: RJR & Co is a regulatory affairs consultancy for medical devices and combination products, including 510(k), PMA, and IDE submissions. Like Cerneos, it pairs submission expertise with quality system (ISO 13485, MDSAP) support.
• StarFish Medical: StarFish Medical provides medical device product development, regulatory affairs, and quality assurance consulting. It is comparable in scope of regulatory services bundled with engineering and design work, addressing similar device and diagnostic clients.

Broad incumbents

• ICON plc: ICON plc is one of the largest global CROs offering regulatory, clinical, bioanalytical, and consulting services. It competes with Cerneos on regulatory strategy engagements for pharma and device clients that need integrated development support.
• Medpace: Medpace is a full-service CRO with strong regulatory and clinical operations capabilities across therapeutic areas. It represents the scaled incumbent alternative for biotech clients considering Cerneos for full development programs.
• Parexel International: Parexel is a top-tier global CRO with deep regulatory consulting offerings across FDA, EMA, and APAC jurisdictions. It is the principal large-cap competitor for clients seeking combined regulatory affairs and clinical services.
• Premier Research: Premier Research is a mid-to-large CRO focused on biotech and specialty pharma across oncology, rare disease, and pediatrics. While broader in scale, it competes with Cerneos for regulatory affairs outsourcing on IND/BLA programs for smaller biotech clients.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/cerneos
• Xx.com/Cerneos
• LinkedInlinkedin.com/company/the-cerneos-group

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

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 Cerneos