NDA Regulatory Service GmbH

What NDA Regulatory Service GmbH does

NDA Regulatory Service GmbH is a Munich-based regulatory affairs consultancy founded in 1997 that serves biotech and pharmaceutical companies developing innovative therapies for US and EU markets. Through its US affiliate SSI Strategy LLC (Morristown, New Jersey) and an Executive Advisory Network, the firm delivers a broad portfolio of drug development services anchored on a Regulatory Affairs core and extending into the Strategic Medical Office, Translational & Clinical Development, Clinical Operations, Evidence & Value (including EU HTA Regulation guidance), Medical Affairs, Program Management & Governance, Quality & Compliance, Safety & PV, and High-Stakes Meetings.

The firm's technical differentiation rests on proprietary regulatory methodologies — notably Target Product Profile (TPP) development, multi-jurisdictional dossier preparation across FDA, EMA, and MHRA, and proactive agency engagement strategy — combined with a leadership team that includes former regulators (e.g., 12 years at the Swedish Medicines Agency, 9 years as Swedish delegate on the EMA Committee for Advanced Therapies) and senior pharma executives (Bristol-Myers Squibb, NDA Group, PharmApprove, Phytomedics). The firm claims to have contributed to the approval of more than 25% of all new medicines in the US and EU over the last five years.

The business operates as a professional services firm, generating revenue through project-based consulting engagements, advisory retainers, and a distinctive fractional/interim executive leadership model that places senior regulatory leaders into biotech teams at fundraising, pivotal filing, and major health authority interaction milestones. Go-to-market is sales-led and content-driven, with top-of-funnel demand generated through podcasts (Regulatory: The Emerging C-Suite Leader, The Emerging Biotech Leader), Build Talks webinars, thought leadership articles, and LinkedIn presence, converting via direct website inquiry, phone, and email. Pricing is quote-based and tailored to scope, with no publicly disclosed rates.

Name

NDA Regulatory Service GmbH

Legal name

SSI Strategy LLC

Website

https://ndareg.com

Company type

Private

Founded year

1997

Operating status

Operating

Headcount range

101–250 employees

Short description

Munich-based regulatory affairs consultancy (founded 1997, 101–250 employees) serving biotech and pharma with drug development advisory spanning regulatory strategy, clinical development, medical affairs, pharmacovigilance, and fractional executive leadership across US and EU markets.

Ownership category

akta.pro rank

Product category

Regulatory Affairs Consulting

NAICS

Management Consulting Services (54161), Other Scientific and Technical Consulting Services (541690)

SIC

Services-Management Consulting Services (8742), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

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

akta.pro secondary industries

Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC), Inspection Readiness & Regulatory Authority Support (FDA/EMA/MHRA) (HLAGAKAF)

Keywords

• Regulatory affairs consulting
• Drug development strategy
• FDA EMA submissions
• Biotech advisory services
• Pharmaceutical regulatory strategy

Headquarters

HQ city

München

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. Regulatory Affairs Consulting: Professional consulting services providing regulatory strategy, scientific advice, and execution support for biotech and pharmaceutical companies developing drugs for US and EU markets. Revenue is generated through project-based engagements and advisory retainers for strategic regulatory leadership.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

NDA Regulatory Service GmbH is a European regulatory affairs consultancy providing strategic regulatory support to biotech and pharmaceutical companies. The firm develops target product profiles, designs multi-jurisdictional regulatory strategies for FDA, EMA, and MHRA submissions, and offers fractional executive regulatory leadership for clients at critical development milestones. Services span the full drug development lifecycle from early translational work through clinical development, evidence generation, medical affairs, quality and compliance, and pharmacovigilance.

Product overview

SSI Strategy offers a comprehensive portfolio of biotech advisory and consulting services organized around a central Regulatory Affairs function. The core offering encompasses regulatory strategy, strategy & leadership, and NDA advisory services, supported by six interconnected service modules: The Strategic Medical Office, Translational & Clinical Development, Clinical Operations, Evidence & Value, Medical Affairs, and Program Management & Governance. Additional specialized services include Quality & Compliance, Safety & PV, High-Stakes Meetings, and an Executive Advisory Network. The company also provides Insights content including podcasts and thought leadership. Services are delivered through senior executive consultants with backgrounds at major pharmaceutical companies and regulatory agencies.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Affairs Consulting
• Regulatory Strategy & Leadership
• NDA Advisory Board
• The Strategic Medical Office
• Translational & Clinical Development
• Clinical Operations
• Evidence & Value
• Medical Affairs
• Program Management & Governance
• Quality & Compliance
• Safety & Pharmacovigilance
• High-Stakes Meetings Advisory
• Executive Advisory Network

Quantifiable outcome

• Contributed to approval of more than 25% of all new medicines in US and EU over the last five years

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators2 records

Recent moves5 records

Expansion highlights6 records

Direct peers

• NDA Group: Likely parent or sister organization of NDA Regulatory Service GmbH, providing the same regulatory affairs consulting, multi-jurisdictional submissions, and drug development advisory services to biotech and pharma clients across Europe. Directly comparable service portfolio and target customer base.
• Worldwide Clinical Trials: Mid-size global CRO with strong regulatory affairs and drug development consulting capabilities serving biotech and pharma. Closely comparable in scale and service mix to NDA Regulatory Service, including FDA/EMA strategy and dossier support.
• Clinipace Worldwide: Mid-size CRO focused on biotech with regulatory affairs, clinical operations, and biostatistics services. Comparable target customer (emerging biotech) and overlapping service portfolio in regulatory strategy and submissions.
• ProPharma Group: Specialized regulatory affairs, compliance, and drug development consulting firm serving pharma and biotech. Comparable boutique model and service offerings in regulatory strategy, submissions, and quality/compliance.
• Biopharma Excellence (an ETHealthworks company): Specialized regulatory and drug development consultancy serving biotech and pharma clients across Europe. Closely comparable boutique offering focused on regulatory strategy, scientific advice, and agency interactions with EMA and FDA.

Broad incumbents

• Parexel International: Global CRO offering regulatory affairs consulting alongside clinical, biometrics, and commercial services. Comparable regulatory strategy offering but as part of a much larger full-service development platform serving the same biotech and pharma clients.
• IQVIA: One of the world's largest CROs with a regulatory affairs practice spanning FDA, EMA, and MHRA submissions. Overlaps with the firm on regulatory strategy and dossier preparation but operates at a vastly larger scale and broader service scope.
• ICON plc: Global CRO with dedicated regulatory services unit supporting INDs, NDAs, MAAs, and agency interactions across major markets. Comparable to the firm's regulatory affairs offering but bundled with much wider clinical and laboratory services.
• Charles River Laboratories: Provides regulatory and drug development consulting alongside its core preclinical and manufacturing services. Comparable regulatory consulting capability but embedded in a much broader life-sciences services platform.
• Covance (Labcorp Drug Development): Offers regulatory affairs consulting as part of a full-service drug development platform. Comparable FDA/EMA submission expertise but operating at much greater scale within Labcorp's broader diagnostics and development business.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/ndagroup
• LinkedInlinkedin.com/company/nda-group-ab

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 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 NDA Regulatory Service GmbH