NDA Partners
NDA Partners is a life sciences management consulting firm providing expert regulatory and product development advisory services to global pharmaceutical, biotechnology, and medical device companies, leveraging a network of former FDA and industry executives; since 2023 it operates as a ProPharma company.
- Company typePrivate
- Founded2013
- HeadquartersRochelle, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What NDA Partners does
NDA Partners LLC is a life sciences management consulting firm founded in 2013 and headquartered in Washington, DC. The firm provides high-value expert advisory services to pharmaceutical, biotechnology, and medical device companies worldwide, supporting the product development life cycle from initial concept through marketing authorization. Its services include product development and regulatory strategy, development program planning and management, expert scientific and technical advice, biostatistics, market access and reimbursement, pediatric development, quality management systems, and litigation support/expert witness services for law firms. The firm operates through six organized Practice Areas: Biologics Development, Medical Device Development, Drug Development, Generics Product Development, Product Quality & CMC Services, and Quantitative Drug Development Strategies. NDA Partners also assembles custom Product Development Teams (PDTs) that design, plan, and manage regulatory and product development programs on behalf of early-stage biopharma and device clients.
The firm's core technology is its curated network of top-tier Expert Consultants — including three former FDA Center Directors, the former CEO/CSO of the United States Pharmacopeial Convention (USP), more than 30 former senior-level regulatory agency executives, and dozens of former pharmaceutical industry senior executives — combined with full-spectrum functional expertise across regulatory, nonclinical, CMC, clinical, and quality domains. This expert network is the platform on which engagements are delivered rather than a software product.
Revenue is generated through professional services engagements priced on a quote basis, with multi-year contracts typical. Customers include global pharmaceutical companies, emerging biopharma, medical device companies, national and global law firms, and private investment firms in the life sciences space. As of 2023, NDA Partners operates as a ProPharma company, having joined ProPharma to scale its consultant base and broaden its service offerings across regulatory sciences, clinical research solutions, life science consulting, pharmacovigilance, and medical information services.
NDA Partners firmographics
Firmographics- Name
- NDA Partners
- Legal name
- NDA Partners LLC
- Website
- https://ndapartners.com
- Company type
- Private
- Founded year
- 2013
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- NDA Partners is a life sciences management consulting firm providing expert regulatory and product development advisory services to global pharmaceutical, biotechnology, and medical device companies, leveraging a network of former FDA and industry executives; since 2023 it operates as a ProPharma company.
- Ownership category
- akta.pro rank
NDA Partners industry classification
Industry- Product category
- Life Sciences Consulting
- NAICS
- Management Consulting Services (54161), Other Scientific and Technical Consulting Services (541690)
- SIC
- Services-Management Consulting Services (8742)
- akta.pro primary industry
- Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH)
- akta.pro secondary industry
- Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)
Keywords
Where NDA Partners is headquartered
LocationHeadquarters
- HQ city
- Rochelle
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
NDA Partners business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D
Revenue model
- Expert Advisory Services: High-value advisory services through Expert Consultants supporting product development life cycle from initial concept to marketing authorization. Includes product development and regulatory strategy, development program planning and management, and expert scientific and technical advice.
- Development Teams: Formation of world-class product development teams (PDTs) for early-stage biopharma and medical device companies that design, plan, and manage regulatory and product development programs.
- Specialized Service Offerings: Biostatistics, market access and reimbursement, pediatrics, and quality management systems consulting services.
- Expert Witness Services: Litigation support services for law firms including expert reports, depositions, and trial testimony for cases involving antitrust violations, patent infringement, product liability, and supply chain failures.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom consulting engagements |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels3 records
NDA Partners product offering
Product offeringCore offering
NDA Partners provides high-value expert consulting services to pharmaceutical, biotechnology, and medical device companies worldwide, covering the full product development life cycle from initial concept through marketing authorization. Core offerings include Expert Advisory Services on regulatory strategy, Product Development Teams (PDTs) that design and manage development programs, and specialized services in biostatistics, market access, pediatrics, quality management systems, and expert witness support for litigation. The firm assigns top-tier Expert Consultants, including former FDA Center Directors and senior industry executives, on every engagement.
Product overview
NDA Partners is a life sciences management consulting organization offering a comprehensive suite of expert consulting services rather than a unified software product. The firm provides Expert Advisory Services, Development Teams (PDTs), and Specialized Service Offerings organized across six Practice Areas: Biologics Development, Medical Device Development, Drug Development, Generics Product Development, Product Quality & CMC Services, and Quantitative Drug Development Strategies. Services span regulatory strategy, biostatistics, market access, pediatrics, quality management systems, and expert witness support. The company recently joined ProPharma, expanding its capabilities in regulatory sciences, clinical research solutions, and pharmacovigilance services.
Differentiator
Problem solved
Functional benefit
Products and services
- Expert Advisory Services High-value advisory services delivered through top-tier Expert Consultants supporting the product development life cycle from initial concept to marketing authorization, including product development and regulatory strategy, development program planning and management, and expert scientific and technical advice, for pharmaceutical, biotechnology, and medical device clients.
- Product Development Teams (PDTs) Formation of world-class product development teams that design, plan, and manage regulatory and product development programs for inventors, IP owners, and early-stage biopharma and medical device companies.
- Biostatistics Services Traditional and advanced statistical expertise for companies developing medical products, including adaptive trial design, Bayesian statistics, and Model-Informed Drug Development.
- Market Access and Reimbursement Services Market access landscape assessments, coding strategy development, and payer dossier preparation for new drugs, biologics, devices, and combination products.
- Pediatrics Services Comprehensive services for pediatric patient development and registration, including pediatric study design, Pediatric Study Plans, and Rare Pediatric Disease Vouchers.
- Quality Management Systems & Quality System Regulation Services Design, implementation, and management of quality and risk management systems, cGMP and cGCP audits, and compliance with ISO 13485 and 21CFR820.
- Expert Witness Services Litigation support services for law firms including expert reports, depositions, and trial testimony in cases involving antitrust violations, patent infringement, product liability, and supply chain failures.
- Biologics Development Practice Expert guidance and support for development of large molecules from initial concept to BLA/MAA/351(k) submission, covering viruses, bacteria, therapeutic serum, toxins, vaccines, blood products, cell and gene therapies, and monoclonal antibodies.
- Medical Device Development Practice Services facilitating development of novel devices including medical equipment, implants, in vitro and imaging diagnostics, mobile and analytical software devices, and combination products.
- Drug Development Practice Support across the product development life cycle for new chemical entities, including integrated product development strategy, clinical study design, and regulatory submissions.
- Generics Product Development Practice Services facilitating development and registration of generic products including ANDA 505(j), 351(k), and 505(b)(2) regulatory pathways.
- Product Quality & CMC Services Practice Focused on requirements for chemically synthesized molecules for 505(b)(1) and 505(b)(2) applications, including biopharmaceutics, microbiology, compliance, and CMC development strategies.
- Quantitative Drug Development Strategies (QDDS) Practice State-of-the-art quantitative methodologies including quantitative clinical pharmacology, PKPD and PBPK modeling, clinical simulation, and adaptive trial designs.
Companies that use NDA Partners
Customer profileNamed customers5 records
Segments5 records
Ideal customer profiles5 records
NDA Partners technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
NDA Partners partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- ProPharmacoreNDA Partners has joined ProPharma, expanding their team of Expert Consultants and service offerings. Together they elevate services as a leading global provider of regulatory sciences, clinical research solutions, life science consulting, pharmacovigilance, and medical information services. NDA Partners is now a ProPharma company, offering expanded capabilities to clients worldwide.
Scale indicators3 records
Recent moves7 records
Expansion highlights6 records
NDA Partners competitors and assessment
Company assessmentDirect peers
- PharmaLex: Global regulatory affairs, pharmacovigilance, and development consulting firm with deep FDA/EMA expertise serving pharma and biotech. Comparable regulatory services portfolio, scaled larger via acquisitions.
- ProPharma Group: Parent organization of NDA Partners since 2023; provides regulatory sciences, clinical research solutions, pharmacovigilance, and life science consulting globally. Direct overlap in regulatory consulting for pharma, biotech, and medical device clients.
- Camargo Pharmaceutical Services: Boutique regulatory and drug development consultancy serving emerging and mid-size pharma with 505(b)(2), ANDA, and full development pathway services. Closely comparable in niche positioning and small-firm, expert-led delivery model.
- Biologics Consulting Group: Specialty regulatory consulting firm staffed largely by former FDA reviewers and industry experts, focused on biologics, cell and gene therapies, and related CMC/regulatory submissions. Comparable expert-network model and FDA alumni bench.
- The Weinberg Group: Regulatory and scientific consulting firm supporting medical device, pharmaceutical, and combination product companies with FDA strategy, submissions, and quality compliance. Comparable in regulatory advisory focus and mid-size boutique scale.
- CTI Clinical Trial & Consulting Services: Mid-size CRO with strong regulatory, clinical development, and product strategy consulting for pharma and biotech, including rare disease and biologics. Comparable in regulatory and development program support with a smaller, expert-led footprint.
Broad incumbents
- ICON plc: Major global CRO providing clinical, regulatory, and consulting services to pharma, biotech, and medical device companies. Overlaps with NDA Partners in regulatory strategy and development consulting at a much larger scale.
- Charles River Laboratories: Global CRO/preclinical services provider with regulatory and development consulting capabilities supporting pharma and biotech product development. Adjacent but broader in scope, with overlapping regulatory consulting offerings.
- IQVIA: Largest global CRO with extensive regulatory affairs, R&D consulting, and product development services for life sciences companies. Competes for the same large-pharma and emerging-biotech clients at a different scale.
- Parexel International: Large global CRO offering regulatory strategy, clinical development, and product development consulting across pharma, biotech, and medical devices. Overlaps with NDA Partners on regulatory advisory but serves a much broader portfolio.
Market position
Strengths5 records
Weaknesses2 records
Competitive moat3 records
Key risks6 records
Key highlights7 records
Customer concentration
NDA Partners social profiles
Digital presenceNDA Partners financial estimates
Financial estimateRevenue estimate
Valuation estimate
NDA Partners leadership team
Management profileNumber of profiles
Profiles15 records
NDA Partners funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
NDA Partners 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 NDA Partners
What does NDA Partners do?
NDA Partners provides high-value expert consulting services to pharmaceutical, biotechnology, and medical device companies worldwide, covering the full product development life cycle from initial concept through marketing authorization. Core offerings include Expert Advisory Services on regulatory strategy, Product Development Teams (PDTs) that design and manage development programs, and specialized services in biostatistics, market access, pediatrics, quality management systems, and expert witness support for litigation. The firm assigns top-tier Expert Consultants, including former FDA Center Directors and senior industry executives, on every engagement.
Is NDA Partners a public or private company?
NDA Partners is a private company. It is classified as corporate owned and is currently operating.
When was NDA Partners founded?
NDA Partners was founded in 2013. It employs 11 to 50 people.
Where is NDA Partners based?
NDA Partners is headquartered in Rochelle, United States, in the North America region.
How does NDA Partners make money?
Four revenue lines are on record. Expert Advisory Services are the primary driver. The others are development Teams, specialized Service Offerings and expert Witness Services.
Who are NDA Partners's main competitors?
Direct peers on record are PharmaLex, ProPharma Group, Camargo Pharmaceutical Services, Biologics Consulting Group, The Weinberg Group and CTI Clinical Trial & Consulting Services. Broad incumbents are ICON plc, Charles River Laboratories, IQVIA and Parexel International.
Does NDA Partners have an API?
No public API is recorded for NDA Partners.
What industry is NDA Partners in?
NDA Partners's product category is Life Sciences Consulting. Its primary akta.pro industry code is HLAIALAH, Regulatory Strategy & IND/NDA/BLA Submissions Support, with a secondary code of HLAGAKAI, Clinical Quality Assurance (GCP QA, TMF/QMS oversight). Its NAICS code is 54161 and its SIC code is 8742.