Duck Flats Pharma

What Duck Flats Pharma does

Duck Flats Pharma (legal entity DUCK FLATS LLC) is a privately held U.S. regulatory and drug development consulting firm founded in the early 2000s and headquartered in Flemington, New Jersey. The firm provides professional services to biotechnology and pharmaceutical companies across the drug development lifecycle, including strategic drug development planning, IND/NDA and briefing document preparation, pharmacokinetic and pharmacodynamic analyses, nonclinical consulting, clinical trial design, and regulatory submission strategy. Its senior practitioners report collective experience managing over 400 regulatory documents, leading 65+ NDAs and 260+ INDs, and supporting FDA and global Advisory Committee initiatives, spanning therapeutic areas such as oncology, cardiovascular, neurology/psychiatry, pediatric medicine, HIV, and infectious disease.

The company operates on a sales-led, direct-engagement model. It does not sell software, APIs, or proprietary technology products; revenue is generated through project-based consulting engagements with enterprise biotech and pharma clients, priced on a quote basis determined during client consultation. Marketing is primarily conducted through the corporate website (dfpharma.com), direct phone and email outreach, and professional networking within the pharmaceutical sector, with no disclosed digital advertising or large-scale demand generation infrastructure. Geographic service scope is described as North America/USA, though individual engagements have included multi-jurisdictional regulatory coordination.

Duck Flats Pharma is a small consultancy (11–50 employees) with no disclosed funding rounds, no parent company, no subsidiaries, no M&A activity, and no public revenue figures. Its most recent disclosed strategic event is a February 2026 partnership with Oragenics to act as the U.S. IND readiness and regulatory execution partner for the intranasal concussion therapy ONP-002, coordinating an Australian Phase 2a trial with a future U.S. Phase 2b regulatory strategy. The firm holds no patents, trademarks, awards, or third-party certifications in the available data.

Name

Duck Flats Pharma

Legal name

DUCK FLATS LLC

Website

https://dfpharma.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

11–50 employees

Short description

Duck Flats Pharma is a U.S. regulatory and drug development consultancy serving biotechnology and pharmaceutical companies with IND/NDA preparation, pharmacokinetic and clinical consulting services across multiple therapeutic areas.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Consulting

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH)

akta.pro secondary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

Keywords

• Regulatory affairs consulting
• Drug development consulting
• Clinical pharmacology services
• IND NDA preparation
• Pharmacokinetics consulting

Headquarters

HQ city

Elbridge

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, Technology or R&D

Revenue model

1. Regulatory and Drug Development Consulting Services: Duck Flats Pharma generates revenue by providing specialized consulting services to biotechnology and pharmaceutical companies. Services include strategic drug development planning, IND/NDA preparation, pharmacokinetics and pharmacodynamics analyses, nonclinical consulting, and clinical trial design support. Revenue is derived from professional services engagements with pharmaceutical clients pursuing drug development programs.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Duck Flats Pharma is a regulatory and drug development consulting firm that supports biotechnology and pharmaceutical companies across the drug development lifecycle. The firm delivers specialized consulting in nonclinical development, pharmacokinetics, clinical pharmacology, and translational medicine, including IND/NDA preparation, PK/PD analyses, nonclinical program design, clinical trial design, and regulatory submission strategy. Services are provided by a team of senior-level professionals with experience managing 400+ regulatory documents, 65+ NDAs, and 260+ INDs.

Product overview

Duck Flats Pharma is a regulatory and clinical drug development consulting firm offering a unified suite of professional services rather than a software product. The company provides Strategic Drug Development Consulting, Key Document Preparation Services, PK + PD Analyses and Statistics, Nonclinical Consulting, Clinical Consulting, and Regulatory Submission Strategies as an integrated portfolio. These services work together to support clients through the complete drug development lifecycle from nonclinical development through IND/NDA submissions and clinical trial design, with expertise spanning multiple therapeutic areas including Oncology, Neurology/Psychiatry, Cardiovascular, and Infectious Disease.

Differentiator

Problem solved

Functional benefit

Quantifiable outcome

• Managed over 400 regulatory documents and/or submissions
• +1 more outcomes

Named customers1 record

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

One partnership is on record.

• OragenicscoreImplementation/ SI/ Consulting Partner · 3 February 2026Duck Flats Pharma was engaged by Oragenics as its U.S. IND readiness and regulatory execution partner. The collaboration supports FDA-facing preparation and clinical trial design for Oragenics' novel intranasal concussion therapy ONP-002. The engagement aims to align the upcoming Phase 2a clinical trial in Australia with U.S. regulatory strategy, positioning Oragenics for future U.S. Phase 2b trials. Duck Flats Pharma brings regulatory expertise to help navigate FDA requirements and ensure clinical trial design meets regulatory standards.

Scale indicators4 records

Recent moves3 records

Expansion highlights3 records

Broad incumbents

• IQVIA: Largest global CRO and life sciences services firm offering regulatory consulting, clinical trial execution, real-world evidence, and technology — competes for the same biotech regulatory engagements as Duck Flats, but as a one-stop platform rather than a boutique.
• Medpace: Mid-to-large CRO with full-service clinical development and a strong regulatory affairs practice, competing with Duck Flats for biotech regulatory and clinical design engagements, but at materially larger scale.
• ICON plc: Global CRO with comprehensive regulatory consulting, clinical operations, and bioanalytical services — competes with Duck Flats on the regulatory and clinical design portion of biotech drug development programs.
• LabConnect (formerly with Fortrea/LabCorp Drug Development): Central laboratory and clinical trial support services provider, with regulatory-adjacent capabilities — competes indirectly with Duck Flats for biotech program support work.

Direct peers

• ProPharma Group: Mid-sized regulatory, compliance, and pharmacovigilance consulting firm serving pharma and biotech with services including IND/NDA support, regulatory strategy, and clinical consulting — directly comparable in scope and target customer to Duck Flats.
• Camargo Pharmaceutical Services: Specialist regulatory consulting firm focused on 505(b)(2) and complex generic development, including IND/NDA preparation, regulatory strategy, and clinical consulting — directly comparable boutique regulatory consultancy serving pharma/biotech clients.
• Worldwide Clinical Trials: Mid-sized global CRO with strong regulatory affairs, clinical pharmacology, and PK/PD consulting — directly comparable to Duck Flats on the clinical pharmacology and regulatory design portions of drug development.

Emerging players

• Atlantic Pharmaceuticals Regulatory Consulting: Smaller regulatory affairs consultancy offering IND/NDA strategy, FDA meeting support, and submission preparation to emerging biotechs — niche direct competitor to Duck Flats in the U.S. regulatory consulting market.
• BlueRidge BioPharma Consulting: Boutique regulatory and clinical development consultancy serving small and mid-sized biotechs with IND strategy, FDA interactions, and clinical program design — closely comparable in scale and positioning to Duck Flats.

Others

• McKinsey & Company (Pharma Practice): Global management consultancy whose pharma and medical products practice offers drug development strategy and R&D advisory to large pharma and biotech — adjacent competitor for high-level regulatory and development strategy engagements that might otherwise go to a specialist firm like Duck Flats.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat2 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/duckflats

Revenue estimate

Valuation estimate

Number of profiles

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 Duck Flats Pharma