Company Background

You are interviewing for the Head of Strategy & Insights role at HelioReg, a venture-backed B2B SaaS company headquartered in Boston. HelioReg builds workflow tools for regulatory affairs (RA), clinical operations, and quality teams in life sciences. The company’s first product—HelioDocs—is a document management and submission assembly tool used by ~85 customers (mostly US-based biotech and specialty pharma). HelioReg has $18M in ARR, growing ~28% YoY, with gross margin of 82%. The customer base is concentrated: the top 15 accounts represent 40% of ARR, and net revenue retention (NRR) is 108%.

HelioReg’s CEO believes the next growth vector is an adjacent product: HelioIntel, an “AI regulatory intelligence” platform designed to help teams interpret scientific literature and regulatory guidance documents and convert them into actionable decisions (e.g., what endpoints are acceptable, what comparators regulators prefer, what post-market surveillance obligations apply, what evidence is needed for a label expansion). The product concept is motivated by customer interviews: RA leaders say they spend significant time reading FDA/EMA guidance, reviewing precedent approvals, and triaging new publications to anticipate regulator questions.

HelioReg has a strong data engineering team (10 engineers, 3 applied scientists) and a compliance/security posture suitable for enterprise procurement (SOC 2 Type II, HIPAA-ready). However, HelioReg has limited in-house regulatory content expertise: only 2 former RA professionals are on staff, and they are currently supporting customer success.

Strategic Situation (Why Now)

Three external forces are pushing HelioReg to decide quickly:

1. Competitive pressure: Two well-funded competitors are bundling “regulatory intelligence” modules into their broader platforms. One competitor recently announced an LLM-based feature that “summarizes guidance and highlights changes” and is using it to upsell enterprise contracts.
2. Regulatory complexity and pace: Customers cite frequent updates (e.g., FDA guidances, EMA reflection papers, ICH guideline revisions) and increasing scrutiny on real-world evidence and AI/ML-enabled devices.
3. Budget scrutiny: Many mid-market life sciences firms are consolidating vendors. HelioReg needs a compelling expansion product to defend renewals and increase NRR.

The CEO has asked you to prepare a recommendation for the board: Should HelioReg launch HelioIntel in the next 9 months, and if so, which segment and go-to-market approach should be prioritized?

Product Concept: HelioIntel

HelioIntel is envisioned as a subscription platform with three core capabilities:

• Literature & guidance ingestion: continuously ingest FDA/EMA/MHRA guidances, ICH documents, selected standards (e.g., ISO where licensed), and peer-reviewed literature feeds.
• Interpretation layer: produce structured outputs such as “key requirements,” “evidence expectations,” “common deficiencies,” “relevant precedents,” and “change impact vs prior version.”
• Workflow integration: link interpretations to internal SOPs, submission sections, and project plans; generate audit-ready traceability.

The product must be careful: customers want speed, but they also need defensible, citable outputs. HelioReg’s legal counsel is concerned about product claims that could be interpreted as “regulatory advice.”

Market Context & Data

HelioReg’s strategy team has assembled the following (imperfect) market inputs for you to use.

Segment options under consideration

Pricing hypotheses (early)

• Team tier: $30K/year (up to 10 users)
• Business tier: $75K/year (up to 40 users)
• Enterprise tier: $180K/year (unlimited users + SSO + audit exports)

Adoption and value assumptions (from interviews)

• A mid-market biopharma RA team reports ~12–20 hours/week per RA professional spent on “monitoring and interpreting” new guidances and literature relevant to active programs.
• Fully loaded cost of an RA professional: $190K/year (salary + benefits + overhead).
• Interviewees claim a strong tool could reduce that time by 20–35%, but only if outputs are trustworthy and traceable.

Competitive landscape (simplified)

Your Deliverables (What you must do)

As the candidate, you are expected to produce a structured recommendation. Address the following:

1. Interpretation approach: Describe how you would interpret scientific literature and regulatory guidance in a way that is reliable enough for regulated decision-making. What is your method, what are the failure modes, and how do you design for traceability?
2. Market sizing: Estimate TAM/SAM/SOM for HelioIntel for the next 3 years, using reasonable assumptions. You may focus on the US and EU markets.
3. Competitive analysis: Use a structured framework (e.g., Porter’s Five Forces) to assess attractiveness and HelioReg’s ability to win.
4. Go-to-market and pricing: Recommend target segment(s), packaging, pricing, and sales motion. Include a 9-month launch plan.
5. Board-level recommendation: Decide whether to launch now, delay, or pivot the concept—and justify with quantitative reasoning.

Constraints

• Timeline: Board wants a go/no-go decision in 4 weeks; if “go,” MVP must launch in 9 months.
• Budget: Incremental budget capped at $6M for the first 12 months (including hiring and data licensing).
• Team capacity: At most 6 engineers and 2 applied scientists can be allocated without jeopardizing HelioDocs roadmap.
• Regulatory/legal: Must avoid claims that constitute “regulatory advice.” Must support auditability and citation.
• Data rights: Some standards (ISO) require licensing; full-text journal access may be limited.