Biotech Consulting
Scientific accuracy thatstill raises money.
Advisory for medical device and health technology companies — product validation, regulatory pathway, clinical workflow, and investor materials that hold up under technical scrutiny.
HIPAA Business Associate Agreement on file
Fig. 01 — Biotech Consulting
01 / The problem
Two audiences,one document.
Medical device and health technology companies have to satisfy reviewers who punish imprecision and investors who punish density — usually in the same deck. Most firms can serve one audience. Getting both requires someone who can read the clinical material and the cap table.
- 01Investor materials that flatten the science until a clinician would not sign them
- 02Regulatory milestones and commercial milestones tangled into one timeline
- 03Clinical workflow designed around the software rather than the care
- 04No credible answer to how the product actually reaches a patient
We don't dress up the science. We make it legible to the people writing the cheque.
The approach
Complex,made legible.
Thousands of vessels, continuous video, geolocation and model output — reduced to a single screen a watch officer can read in a glance. Whatever the domain, that reduction is the work: the hard part is never gathering the data, it is deciding what a person needs to see and hiding everything else.
Fig. — one screen standing in for a whole system
02 / What we do
Scientific consultation
Structured review of the underlying science and what it does and does not yet support.
- Scientific review memo
- Evidence gap analysis
- Literature positioning
Product validation
Establishing whether the thing works, for whom, and against what comparator.
- Validation plan
- Comparator analysis
- Endpoint definition
Regulatory guidance
Pathway orientation and the milestone structure that follows from it, including 510(k) literacy for device companies.
- Regulatory pathway assessment
- Milestone and evidence roadmap
- Submission readiness review
Clinical workflow consulting
Designing the product around how care is actually delivered, rather than around the data model.
- Care pathway mapping
- Clinical workflow design
- Adoption and training plan
Healthcare technology advisory
Where the software meets the clinic — integration, data handling and the operational reality of deployment.
- Technology architecture review
- Data handling assessment
- Deployment plan
Investor materials
Decks and memos for medical audiences, where credibility outperforms polish.
- Investor deck
- Market sizing by clinical segment
- Clinical and commercial milestone structure
03 / Proof
04 / How we work
Every step ends in somethingyou can hold.
Technical read
We work through the science, the regulatory position and the clinical claim as written.
- Deliverable
- Technical assessment
- Timing
- Weeks 1–2
Pathway and evidence
What regulatory route the product is on, and what evidence that route demands.
- Deliverable
- Pathway and evidence roadmap
- Timing
- Weeks 2–4
Commercial translation
Market sizing by clinical segment, and the milestone structure investors will hold you to.
- Deliverable
- Commercial case
- Timing
- Weeks 4–6
Materials
The deck, memo or submission-support pack the next conversation requires.
- Deliverable
- Investor or submission materials
- Timing
- Weeks 5–7
05 / Portfolio
ENT Medical Device Seed Round
Investor deck for a $500K SAFE in procedural intelligence
AAV Gene Therapy — Structural Biology Research
Peer-reviewed cryo-EM work on the only FDA-approved gene therapy vector
Verified reviews
Checkable,not curated.
Our contract history and client feedback sit on Upwork, where the rating and the value of each engagement are published alongside the words. These profiles span every practice, not just this one.
Byte Advisory
Agency profileThe firm's agency profile — completed contracts and client feedback across every practice.
Reviews on Upwork ↗Ali K. Rizvi
CEO & Financial ConsultantProject history spanning finance and modelling, web, marketing, design and copywriting.
Reviews on Upwork ↗Onellah Weerakoon
Managing Director, BiotechBiochemistry, gene therapy and life sciences research, with published portfolio and project history.
Reviews on Upwork ↗06 / Who does this work
Managing Director, Biotech
Scientific consultation, product validation, medical research guidance, regulatory recommendations and clinical workflow consulting.
Technical Lead
Solution architecture and technology selection for clinical software, including accessibility compliance.
FAQ
Questions we getasked.
Do you handle regulatory submissions?
We provide pathway assessment, evidence roadmaps and submission readiness review, and we work alongside your regulatory counsel. We are advisors on the pathway, not your regulatory agent of record.
How do you handle protected health information?
We hold a Business Associate Agreement and work under it where an engagement touches PHI. Where possible we design engagements so it never reaches us — the health platforms in our portfolio run entirely on synthetic data.
What does a typical biotech engagement look like?
Most begin as a defined project — a pathway assessment, a validation plan, or an investor deck — running four to seven weeks. Ongoing advisory follows where it is useful.
Bring the problem.
Thirty minutes, no charge, and a straight answer on scope and whether we are the right firm for it.
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