Biologics Consulting
Biologics Consulting is a privately held FDA regulatory affairs and product development consulting firm founded in 1993, serving biologics, pharmaceutical, medical device, and combination product sponsors across 58 countries with 65+ regulatory experts, including former US FDA professionals.
- Company typePrivate
- Founded1993
- HeadquartersAlexandria, United States
- Headcount51–100
- GTM typeB2B
- OfferingServices
What Biologics Consulting does
Biologics Consulting Group, Inc. (operating as Biologics Consulting) is a privately held FDA regulatory affairs and product development consulting firm headquartered in Alexandria, Virginia. Founded in 1993, the firm provides integrated multidisciplinary regulatory strategy and operations support to companies developing biologics, pharmaceuticals, medical devices, and combination products seeking US market authorization. The firm is structured as an Employee Stock Ownership Plan (ESOP), led by CEO Margaret Vernon, PhD, and CFO Andrew Zurlo, and reports 30+ years of operating history with 4,700+ professionally serviced projects across 58 countries.
The firm's service portfolio is organized around four product-aligned verticals — Drugs & Biologics, Medical Devices, Combination Products, and Cell & Gene Therapy — supported by specialized technical groups in Chemistry, Manufacturing & Controls (CMC), Nonclinical Pharmacology/Toxicology, Clinical Development, Regulatory Affairs, and Regulatory Operations/ePublishing. Delivery is anchored by a team of 65+ regulatory experts, including former US FDA professionals, and is augmented by a strategic partner network spanning CMC compliance, toxicology strategy, cell therapy microbiology, and international regulatory coverage across 95+ countries (via partners such as RJR Consulting).
The firm operates a quote-based professional services model with project and multi-year retainer engagements priced on scope, expertise, and duration. Go-to-market is predominantly direct enterprise sales to biotech, pharma, and device sponsors, supplemented by thought leadership through webinars, podcasts, articles, and participation in industry conferences (DIA, RAPS, BIO, SOT, Festival of Biologics, Bioprocessing Summit). Revenue, customer-level concentration, and financial performance are not publicly disclosed.
Biologics Consulting firmographics
Firmographics- Name
- Biologics Consulting
- Legal name
- Biologics Consulting Group, Inc.
- Website
- http://www.biologicsconsulting.com
- Company type
- Private
- Founded year
- 1993
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Biologics Consulting is a privately held FDA regulatory affairs and product development consulting firm founded in 1993, serving biologics, pharmaceutical, medical device, and combination product sponsors across 58 countries with 65+ regulatory experts, including former US FDA professionals.
- Ownership category
- akta.pro rank
Biologics Consulting industry classification
Industry- Product category
- FDA Regulatory Affairs Consulting
- NAICS
- Management Consulting Services (54161), 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)
Keywords
Where Biologics Consulting is headquartered
LocationHeadquarters
- HQ city
- Alexandria
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Biologics Consulting business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales
Revenue model
- Regulatory Consulting Services: Professional consulting services for FDA regulatory affairs, CMC development, nonclinical development, clinical development, regulatory operations, and quality assurance for biologics, pharmaceuticals, medical devices and combination products
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom project-based consulting engagements |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
Biologics Consulting product offering
Product offeringCore offering
Biologics Consulting is an FDA regulatory affairs and product development consulting firm that delivers integrated multidisciplinary regulatory strategy and operations support for biologics, pharmaceuticals, medical devices, and combination products. Services span CMC, nonclinical, clinical development, regulatory affairs, and regulatory operations/ePublishing, supporting clients from early-stage development through FDA licensure and commercialization. The firm also provides US Agent services, staff augmentation, and global support for companies seeking US market entry.
Product overview
Biologics Consulting is a regulatory affairs and product development consulting firm that offers integrated multidisciplinary services for biologics, pharmaceuticals, medical devices, and combination products. The company operates as a unified consulting platform organized into distinct service lines: Drugs & Biologics Services, Medical Devices Services, Combination Products Services, and Cell & Gene Therapy Services. These core service areas are supported by specialized technical groups including Chemistry, Manufacturing & Controls (CMC), Nonclinical Pharmacology/Toxicology, Clinical Development, Regulatory Operations (ePublishing/Submissions), and Regulatory Affairs. The firm also provides specific features such as Drug & Device Strategy Alignment, Quality Systems & Remediation, FDA Submissions, and FDA Meeting Preparation & Engagement. Services are delivered by former FDA professionals and industry experts with over 30 years of experience.
Differentiator
Problem solved
Functional benefit
Products and services
- Drugs & Biologics Services
Quantifiable outcome
- 4,700+ professionally serviced projects
- +1 more outcomes
Companies that use Biologics Consulting
Customer profileNamed customers1 record
Segments4 records
Ideal customer profiles4 records
Biologics Consulting technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Biologics Consulting partnerships and signals
Strategic signalPartnerships
Ten partnerships are on record, tiered minor.
- Dans-K ConsultingminorStrategic partner providing additional consulting capabilities within the Biologics Consulting network.
- GenedriftminorPartner organization within the Biologics Consulting partner network.
- Lighthouse BiosolutionsminorPartner organization within the Biologics Consulting partner network.
- Royalmount LaboratoriesminorPartner organization within the Biologics Consulting partner network.
- CMC Compliance ServicesminorPartner organization providing CMC compliance services within the Biologics Consulting network.
- AsphalionminorPartner organization within the Biologics Consulting partner network.
- Arlington BiomedicalminorPartner organization within the Biologics Consulting partner network.
- Cell Therapy MicrobiologyminorPartner organization providing cell therapy microbiology expertise within the Biologics Consulting network.
- ToxistrategyminorPartner organization providing toxicology strategy services within the Biologics Consulting network.
- RJR ConsultingminorPartner with regulatory compliance coverage in 95+ countries including U.S./International client services with offices in Columbus, Ohio; Brussels, Belgium; Dubai, UAE; Sao Paulo, Brazil; Mexico City, Mexico; Buenos Aires, Argentina; and affiliates in Canada, Japan, S. Korea, Singapore, India, Taiwan, China, Philippines, Malaysia, MENA Nations, South Africa and additional countries globally. Industry coverage includes Pharmaceuticals/Biologics/Medical Devices/IVDs/Combination Products/Dietary Supplements/Personal Care/Cosmetics.
Scale indicators4 records
Recent moves6 records
Expansion highlights5 records
Biologics Consulting competitors and assessment
Company assessmentBroad incumbents
- Parexel International: Parexel is a global CRO offering regulatory affairs, clinical, and biopharmaceutical services to pharma and biotech. It is a broad incumbent that competes for regulatory consulting work as part of a much larger full-service CRO portfolio.
- IQVIA: IQVIA is the largest global CRO with extensive regulatory affairs, eCTD publishing, CMC, and clinical development services. It is a broad incumbent that competes head-to-head with Biologics Consulting on enterprise regulatory engagements.
- ICON plc: ICON is a global CRO providing regulatory, clinical, and laboratory services across all phases of drug and biologic development. It is a broad incumbent competing for FDA submission and regulatory affairs work at large sponsors.
- Charles River Laboratories: Charles River is a global CRO/CDMO with regulatory consulting, safety assessment, and biologics development capabilities. It is a broad incumbent that overlaps with Biologics Consulting on regulatory strategy and CMC for biologics.
Direct peers
- NSF (formerly NSF Health Sciences): NSF's Health Sciences division provides regulatory and quality consulting, training, and auditing for pharma, biologics, and medical device companies. It is a direct peer in FDA regulatory affairs, quality systems, and compliance consulting.
- The Weinberg Group: The Weinberg Group is a regulatory and product development consultancy for medical devices, drugs, biologics, and combination products. It is a direct peer with overlapping FDA strategy, submission, and quality systems offerings.
- Greenleaf Health: Greenleaf Health is an FDA regulatory consulting firm led by former senior FDA officials, providing regulatory strategy, policy, and compliance services. It is a direct peer with comparable former-FDA talent positioning and biotech/pharma client base.
- ProPharma Group: ProPharma Group is a regulatory, compliance, and quality consulting firm serving pharmaceutical, biologic, and medical device companies. It is a direct peer with comparable FDA-focused regulatory affairs, CMC, and quality systems services, and similar boutique-to-mid-market scale.
- Pharmalex: Pharmalex is a regulatory affairs and pharmacovigilance consultancy serving pharma and biotech across Europe, the US, and Asia. It is a direct peer offering regulatory strategy, submissions, CMC, and lifecycle management support to biologics and drug developers.
Emerging players
- RegDesk (formerly RegPartners): RegDesk is a regulatory affairs consultancy and technology platform serving pharma, biotech, and medical device companies. It is an emerging player with comparable FDA submission and strategy services but with a heavier software/automation angle.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks2 records
Key highlights7 records
Customer concentration
Biologics Consulting social profiles
Digital presenceBiologics Consulting financial estimates
Financial estimateRevenue estimate
Valuation estimate
Biologics Consulting leadership team
Management profileNumber of profiles
Profiles9 records
Biologics Consulting funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Biologics 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 Biologics Consulting
What does Biologics Consulting do?
Biologics Consulting is an FDA regulatory affairs and product development consulting firm that delivers integrated multidisciplinary regulatory strategy and operations support for biologics, pharmaceuticals, medical devices, and combination products. Services span CMC, nonclinical, clinical development, regulatory affairs, and regulatory operations/ePublishing, supporting clients from early-stage development through FDA licensure and commercialization. The firm also provides US Agent services, staff augmentation, and global support for companies seeking US market entry.
Is Biologics Consulting a public or private company?
Biologics Consulting is a private company. It is classified as management employee owned and is currently operating.
When was Biologics Consulting founded?
Biologics Consulting was founded in 1993. It employs 51 to 100 people.
Where is Biologics Consulting based?
Biologics Consulting is headquartered in Alexandria, United States, in the North America region.
How does Biologics Consulting make money?
One revenue line is on record: regulatory Consulting Services.
Who are Biologics Consulting's main competitors?
Broad incumbents on record are Parexel International, IQVIA, ICON plc and Charles River Laboratories. Direct peers are NSF (formerly NSF Health Sciences), The Weinberg Group, Greenleaf Health, ProPharma Group and Pharmalex. RegDesk (formerly RegPartners) is listed as an emerging player.
Does Biologics Consulting have an API?
No public API is recorded for Biologics Consulting.
What industry is Biologics Consulting in?
Biologics Consulting's product category is FDA Regulatory Affairs Consulting. Its primary akta.pro industry code is HLAGAKAA, Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA). Its NAICS code is 54161 and its SIC code is 8742.