NDA Group AB

NDA Group AB provides specialized regulatory consulting to pharmaceutical and biotechnology companies, guiding them through complex drug development and approval processes. The firm crafts comprehensive regulatory strategies, facilitates interactions with global health authorities like the FDA and EMA, and develops multi-jurisdictional dossiers, accelerating market entry.

Founded in 1997 by Birgitta Bergstrand and Lars-Helge Strömquist, NDA Group AB originated from the insight that specialized regulatory expertise was vital for navigating the evolving pharmaceutical development landscape. They recognized the critical need for strategic guidance, bridging the gap between innovative life science companies and global health authority requirements.

NDA Group AB serves a broad clientele across pharmaceutical and biotechnology sectors. The company’s vision centers on enabling faster patient access to innovative therapies by ensuring robust and efficient global regulatory pathways. Leveraging deep regulatory knowledge, they empower clients to successfully navigate approvals and bring vital medicines to market.

NDA Group AB is an independent regulatory and drug‑development consulting firm that helps biotech and pharmaceutical companies navigate regulatory affairs, health‑technology assessment (HTA), pharmacovigilance and quality‑assurance work so that medicines reach patients faster and with compliant dossiers. [1][3]

High‑Level Overview

• Mission: Ensure that good medicines reach patients without unnecessary delay by providing expert regulatory, HTA, pharmacovigilance and QA support to drug developers.[3][1]
  - Investment philosophy / Key sectors / Impact on startup ecosystem: NDA Group is not an investment firm but a professional services firm focused on the life‑sciences sector—primarily pharmaceuticals, biotech and related health technologies—so its “impact” on startups comes from accelerating regulatory strategy, submissions and market access rather than providing capital.[3][1]
  - What it does (product & customers): NDA provides regulatory consulting services and development support to biotech and pharma companies worldwide, serving emerging biotechs, mid‑sized pharma and larger organisations that need regulatory, HTA, safety and quality expertise.[1][3]
  - Problem solved & growth momentum: It solves the complex regulatory, safety and market‑access problems that slow clinical development and approvals; the firm reports long experience (≈25+ years), a team of ~150 consultants and contribution to a substantial share of recent approvals in Europe and the US, indicating steady growth and market penetration.[2][1]

Origin Story

• Founding year & evolution: NDA traces back roughly to the late 1990s and positions itself as a 25+ year‑old independent consulting group operating across Sweden, Germany, Switzerland, the UK and the USA, having expanded its geographic footprint and service portfolio over time to cover regulatory affairs, HTA, pharmacovigilance and quality assurance.[2][3]
  - People & early traction: The organisation emphasizes that a considerable share of its consultants are ex‑regulators and it maintains an Advisory Board of leading regulatory and HTA experts; NDA reports having supported a large proportion of new medicinal products approved in the EU and the US during recent multi‑year periods, which served as pivotal credibility for growth.[3][1]

Core Differentiators

• Experienced regulatory team: Over 150 dedicated consultants with substantial industry and agency backgrounds, including a meaningful proportion of ex‑regulators from major EU agencies, which strengthens dossier strategy and agency interactions.[1][3]
  - Advisory Board & expert network: A specialist Advisory Board of Europe’s regulatory and HTA experts and a network of >1,000 external scientific, clinical and regulatory experts to handle complex or niche issues.[1]
  - Broad, end‑to‑end service scope: Services span all phases of drug development and major therapeutic areas—regulatory strategy, dossier preparation and submission, pharmacovigilance, HTA and QA—allowing clients to centralize regulatory and compliance needs.[1][3]
  - Proven track record: Public descriptions state NDA supported a large share of new medicinal product approvals in the EU (historically cited ~40% for certain multi‑year windows) and a sizeable portion of recent approvals in the US and Europe, signifying demonstrable impact on successful filings.[1][2]
  - Global footprint with local regulatory expertise: Presence across multiple European countries plus US operations enables combined global strategy and local agency know‑how.[3]

Role in the Broader Tech / Life‑Sciences Landscape

• Trend alignment: NDA sits at the intersection of rising regulatory complexity, accelerated approval pathways, increasing HTA scrutiny for reimbursement and the proliferation of complex modalities (e.g., cell & gene therapies) that require specialized regulatory and safety expertise.[1][3]
  - Timing: As regulators adopt new frameworks for advanced therapies and as payers demand stronger health‑economic evidence, experienced regulatory/HTA advisors become more valuable—favoring firms like NDA that combine agency experience and HTA capability.[1][3]
  - Market forces in their favor: Continued biotech financing and innovation create persistent demand for external regulatory and safety expertise by companies that lack large in‑house regulatory affairs departments.[2][1]
  - Influence on ecosystem: By helping translate scientific programs into approvable and reimbursable submissions, NDA effectively shortens time‑to‑market and can increase the success rate of small and mid‑sized developers, thereby de‑risking programs for investors and accelerating patient access.[3][1]

Quick Take & Future Outlook

• Near term: Expect continued demand for NDA’s services as drug modalities grow more complex and as HTA / payer evidence requirements tighten; growth likely driven by advisory engagements on advanced therapies, cross‑border submissions and combined regulatory/HTA strategies.[1][3]
  - Competitive pressures & opportunities: Competition from other regulatory consultancies and in‑house teams exists, but NDA’s concentration of ex‑regulators, advisory board and broad service offering are sustainable advantages; opportunities include expanding programmatic offerings for cell/gene therapies and digital therapeutics where regulatory pathways are evolving.[1][3]
  - How their influence may evolve: If NDA continues to demonstrate high success rates on approvals and market‑access outcomes, it could deepen partnerships with VCs and incubators as the preferred regulatory/HTA advisor for portfolio companies—effectively becoming a go‑to operating partner for startups seeking efficient paths to approval and reimbursement.[3][2]

If you’d like, I can: provide a concise competitor map (other regulatory consultancies and their relative strengths), compile recent public case examples of NDA’s role in specific approvals, or draft outreach language to engage NDA for an advisory project.