Biologics Consulting

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.

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

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

• FDA regulatory consulting
• Biologics product development
• Medical device regulatory affairs
• Cell and gene therapy consulting
• Combination products regulatory

Headquarters

HQ city

Alexandria

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales

Revenue model

1. 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

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core 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

Named customers1 record

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Ten partnerships are on record, tiered minor.

• Dans-K ConsultingminorStrategic or Co-development PartnerStrategic partner providing additional consulting capabilities within the Biologics Consulting network.
• GenedriftminorStrategic or Co-development PartnerPartner organization within the Biologics Consulting partner network.
• Lighthouse BiosolutionsminorStrategic or Co-development PartnerPartner organization within the Biologics Consulting partner network.
• Royalmount LaboratoriesminorStrategic or Co-development PartnerPartner organization within the Biologics Consulting partner network.
• CMC Compliance ServicesminorStrategic or Co-development PartnerPartner organization providing CMC compliance services within the Biologics Consulting network.
• AsphalionminorStrategic or Co-development PartnerPartner organization within the Biologics Consulting partner network.
• Arlington BiomedicalminorStrategic or Co-development PartnerPartner organization within the Biologics Consulting partner network.
• Cell Therapy MicrobiologyminorStrategic or Co-development PartnerPartner organization providing cell therapy microbiology expertise within the Biologics Consulting network.
• ToxistrategyminorStrategic or Co-development PartnerPartner organization providing toxicology strategy services within the Biologics Consulting network.
• RJR ConsultingminorStrategic or Co-development PartnerPartner 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

Broad 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

• LinkedInlinkedin.com/company/biologics-consulting-group
• Facebookfacebook.com/biologics-consulting-group-113715148671938

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 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 Biologics Consulting