Pharmefex Consulting
Pharmefex Consulting is a Bellevue, WA-based CMC consulting firm founded in 2014 that provides technical, regulatory, and compliance services to pharmaceutical and biotechnology clients developing biologics, cell therapies, gene therapies, antibodies, and biosimilars worldwide.
- Company typePrivate
- Founded2014
- HeadquartersBellevue, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Pharmefex Consulting does
Pharmefex Consulting is a privately held professional services firm founded in 2014 and headquartered in Bellevue, Washington. The company provides integrated CMC (Chemistry, Manufacturing and Controls) consulting to pharmaceutical and biotechnology companies developing biologics, cell therapies, gene therapies, antibodies, ADCs, biosimilars, and viral vector products. Its offering is organized around six core service modules: Product/Process & Analytical Development, Manufacturing Strategy & Operations, Outsourcing and Supply Chain Management, Quality & Regulatory, Risk Management, and Program Management. Engagement models are project-based consulting and retainer arrangements delivered directly to clients, with pricing determined per engagement rather than via published rate cards.
Delivery is executed by a distributed network of approximately 40+ senior consultants, most holding Ph.D. or MD/Ph.D. credentials and many with prior operating roles at major biopharma organizations including Amgen, Genentech, Kite (Gilead), Bristol Myers Squibb, Celgene, Juno, Dendreon, Merck, and Lonza. The core employee base is reported as 1-10, indicating that the consultant bench largely operates under independent or contract relationships with the firm. Pharmefex has supported 128+ clients globally, contributed to 17+ regulatory submissions, and claims involvement in 5 commercial approvals.
The go-to-market motion is sales-led and predominantly referral-driven, supplemented by content marketing through the company website, LinkedIn presence, and thought-leadership at industry conferences (PDA Annual Meeting, BPI West, IBC Cell and Gene Therapy Conference). The firm has built a portfolio of reciprocal partnerships with complementary consultancies (Dahlia Consulting, Cascadia Drug Development Group, Jeff Yuen and Associates, Beck Life Sciences, FlexPoint Bio, cGMPnow) to broaden its delivery scope without expanding its own W-2 base. No external funding rounds, parent company, or public equity involvement are evidenced in the source data.
Pharmefex Consulting firmographics
Firmographics- Name
- Pharmefex Consulting
- Legal name
- Pharmefex, LLC
- Website
- https://pharmefex.com
- Company type
- Private
- Founded year
- 2014
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Pharmefex Consulting is a Bellevue, WA-based CMC consulting firm founded in 2014 that provides technical, regulatory, and compliance services to pharmaceutical and biotechnology clients developing biologics, cell therapies, gene therapies, antibodies, and biosimilars worldwide.
- Ownership category
- akta.pro rank
Pharmefex Consulting industry classification
Industry- Product category
- Biopharmaceutical CMC Consulting
- NAICS
- Management Consulting Services (54161)
- SIC
- Services-Management Consulting Services (8742)
- akta.pro primary industry
- CMC & Pharmaceutical Development (Formulation/Process/Analytical Development) (HLAIALAD)
- akta.pro secondary industries
- Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA), Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)
Keywords
Where Pharmefex Consulting is headquartered
LocationHeadquarters
- HQ city
- Bellevue
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Pharmefex Consulting business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Infrastructure
Revenue model
- Consulting Services: Professional consulting services providing technical, regulatory, and compliance expertise for biopharmaceutical development. Services are delivered through project-based engagements, retainer arrangements, and specialized consulting support for CMC development, regulatory submissions, and manufacturing strategy.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels5 records
Pharmefex Consulting product offering
Product offeringCore offering
Pharmefex provides expert CMC (Chemistry, Manufacturing and Controls) consulting services for biopharmaceutical companies developing biologics, cell therapies, gene therapies, antibodies, ADCs, biosimilars, virology products, and non-viral gene delivery systems. Its offerings span product/process and analytical development, manufacturing strategy and operations, outsourcing and supply chain management, quality and regulatory affairs, risk management, and program management, delivered through project-based and retainer engagements by senior industry consultants.
Product overview
Pharmefex Consulting is a professional services firm providing integrated CMC (Chemistry, Manufacturing and Controls) consulting for biologics and advanced therapies. The company offers six core consulting service modules—Product/Process & Analytical Development, Manufacturing Strategy & Operations, Outsourcing & Supply Chain Management, Quality & Regulatory, Risk Management, and Program Management—that work together to support clients from discovery through commercialization. These services support a portfolio of therapeutic product categories including recombinant proteins, biosimilars, cell and gene therapies (with viral vectors), and monoclonal antibodies/antibody-drug conjugates. The company operates as a consulting firm rather than a software product platform, with services delivered by a team of scientific and regulatory consultants with industry experience from major biopharmaceutical companies.
Differentiator
Problem solved
Functional benefit
Products and services
- Product, Process & Analytical Development Services Consulting services for cell line development, upstream and downstream process development, analytical method development, formulation design, and technology transfer support for biologics and cell therapies. Targets pharmaceutical and biotechnology R&D teams building CMC packages for new biologic products.
- Manufacturing Strategy & Operations Services Operational consulting for manufacturing decisions, outsourcing management, facility design, equipment selection, cGMP compliance audits, and validation support for biologics manufacturing. Serves pharmaceutical and biotech manufacturing and technical operations leaders.
- Outsourcing and Supply Chain Management Services CMC outsourcing strategy and supply chain management including CMO/CRO selection, contract negotiation, technology transfer, logistics, cold chain management, and inventory planning. Used by biotech and pharma companies structuring CDMO partnerships and managing biologics supply chains.
- Quality & Regulatory Services Quality system design and implementation, cGMP compliance audits, regulatory submission preparation (IND, BLA), FDA meeting support, mock inspections, and corrective/preventive action development for biologic, cell therapy, and gene therapy programs. Targets regulatory affairs and quality leaders in pharma and biotech.
- Risk Management Services
Quantifiable outcome
- Over 128 clients supported worldwide
- +3 more outcomes
Companies that use Pharmefex Consulting
Customer profileNamed customers3 records
Segments3 records
Ideal customer profiles3 records
Pharmefex Consulting technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Pharmefex Consulting partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered core and supporting.
- Dahlia ConsultingcoreStrategic partnership based on shared values and standards of quality. Dahlia is a global consulting firm providing project and program management, facility construction management, business operations, operational readiness, Quality and Compliance, and market access & reimbursement services. This partnership expands the scope of service both companies can provide to clients worldwide.
- Beck Life SciencescoreBeck Life Sciences LLC is a leading Engineering, Procurement, and Construction firm. Through this partnership, Pharmefex can offer a more extensive portfolio of services while remaining focused on being the premier provider of CMC consulting expertise. Beck can extend its expertise and technologies to Pharmefex clients worldwide, and Pharmefex makes available its biologics and cell therapy expertise to Beck Life Sciences' clients.
- Jeff Yuen and AssociatescoreJeff Yuen & Associates (JYA) is a respected domestic and international consulting firm comprised of former regulators and industry experts providing GMP audit and training, regulatory services, facility reviews, mock inspections and other services worldwide. Partnership expands the scope of outstanding service JYA and Pharmefex can provide their clients.
- Cascadia Drug Development Group (CDDG)corePharmefex specializes in CMC consulting and helps organizations streamline process development, accelerate time to market, reduce cost of goods, manage technology transfers, prepare regulatory submissions, and prevent and resolve manufacturing and compliance problems. CDDG provides oversight of drug development from discovery to early clinical development and offers subject matter expertise in key translational sciences through their network of vetted affiliates.
- FlexPoint BiosupportingFlexPoint Bio is a specialized consulting firm helping small to mid-sized biotechnology companies advance clinical development through expert support in biomarker strategy, biospecimen logistics, vendor selection and oversight, and AI integration. Partnership supplements Pharmefex's expertise and capacity.
- cGMPnowsupportingcGMPnow delivers Turnkey GMP Systems that accelerate Next Generation Therapies to patients. Their expertise spans GMP facility due diligence, design, and regulatory compliance, providing turnkey systems from streamlined equipment procurement and automation to full facility validation.
Scale indicators5 records
Recent moves6 records
Expansion highlights4 records
Pharmefex Consulting competitors and assessment
Company assessmentOthers
- Catenion: Life sciences strategy consultancy advising biopharma on R&D portfolio and corporate strategy; adjacent positioning rather than direct CMC consulting.
- Proventa International: Pharmaceutical industry consulting firm focused on process, quality, and operational improvement; adjacent consulting peer for the same pharma clients.
Broad incumbents
- Parexel International: Global CRO offering regulatory and CMC advisory as part of a much larger clinical development portfolio; broader and larger player overlapping with Pharmefex's regulatory submission work.
- PPD (Thermo Fisher Scientific): Global CRO, now part of Thermo Fisher, providing regulatory affairs and biotech consulting alongside clinical services—large incumbent competing for CMC and regulatory engagement work.
- ICON plc: Global CRO and consulting services provider with regulatory and CMC capabilities bundled into much larger clinical operations and biotech services—competes for the same client budgets.
Direct peers
- Latham BioPharm Group: Specialist regulatory and CMC consulting firm serving biopharma, with overlapping service modules in regulatory strategy, CMC, and quality—closely comparable to Pharmefex's core offering.
- Halloran Consulting Group: US-based life sciences consultancy providing regulatory affairs, CMC, quality, and clinical development services to pharma and biotech—directly comparable to Pharmefex's CMC/regulatory focus.
- NDA Group: Regulatory and CMC advisory firm supporting pharma across development, submissions, and quality—directly comparable in scope and client base.
- BioPharma Services Group: CMC-focused consultancy offering regulatory submissions, quality, and product development support to biopharma clients—comparable niche specialist position to Pharmefex.
- Voisin Consulting Life Sciences: European-rooted regulatory, CMC and quality consulting firm with biologics/cell therapy coverage; offers comparable CMC and global submission expertise to Pharmefex.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
Pharmefex Consulting social profiles
Digital presencePharmefex Consulting financial estimates
Financial estimateRevenue estimate
Valuation estimate
Pharmefex Consulting leadership team
Management profileNumber of profiles
Profiles6 records
Pharmefex Consulting funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Pharmefex Consulting M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Pharmefex Consulting
What does Pharmefex Consulting do?
Pharmefex provides expert CMC (Chemistry, Manufacturing and Controls) consulting services for biopharmaceutical companies developing biologics, cell therapies, gene therapies, antibodies, ADCs, biosimilars, virology products, and non-viral gene delivery systems. Its offerings span product/process and analytical development, manufacturing strategy and operations, outsourcing and supply chain management, quality and regulatory affairs, risk management, and program management, delivered through project-based and retainer engagements by senior industry consultants.
Is Pharmefex Consulting a public or private company?
Pharmefex Consulting is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Pharmefex Consulting founded?
Pharmefex Consulting was founded in 2014. It employs 1 to 10 people.
Where is Pharmefex Consulting based?
Pharmefex Consulting is headquartered in Bellevue, United States, in the North America region.
How does Pharmefex Consulting make money?
One revenue line is on record: consulting Services.
Who are Pharmefex Consulting's main competitors?
Others on record are Catenion and Proventa International. Broad incumbents are Parexel International, PPD (Thermo Fisher Scientific) and ICON plc. Direct peers are Latham BioPharm Group, Halloran Consulting Group, NDA Group, BioPharma Services Group and Voisin Consulting Life Sciences.
Does Pharmefex Consulting have an API?
No public API is recorded for Pharmefex Consulting.
What industry is Pharmefex Consulting in?
Pharmefex Consulting's product category is Biopharmaceutical CMC Consulting. Its primary akta.pro industry code is HLAIALAD, CMC & Pharmaceutical Development (Formulation/Process/Analytical Development), with a secondary code of HLAGAKAA, Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA). Its NAICS code is 54161 and its SIC code is 8742.