Solutions · Emerging Biotech
A lean team that operateslike a much larger one.
Sofie gives a small CMC, quality and regulatory team the capacity to prepare submissions, manage CDMO partners and keep pace with regulators, with your experts in control of every decision.
Run · task breakdown
Orchestrations: coordinated agents with review points where your experts decide.
Anemergingbiotechoftenhasonepersonwherealargecompanyhasadepartment.Sofiedoesnotreplacethatperson.Itgivesthemtheleverageofthedepartment.
Work Sofie takes on
Work Sofie takes on for an emerging biotech
A cross-category set for teams preparing for the clinic and working through partners.
01
CMC Regulatory Strategy
Regulatory & CMC · Workflow
Turn your product context, prior filings and CMC evidence into a defensible multi-market CMC regulatory strategy — sequence, established conditions, data gaps and decisions — in an afternoon, not a month of workshops.
Manual effort today
Weeks of workshops producing a slide with market columns and dates nobody can trace to data
02
CMC Dossier Section (CTD)
Regulatory & CMC · Workflow
Turn your development and manufacturing data into CTD-structured Module 3 content — in an afternoon, not weeks.
Manual effort today
40+ hours across CMC, regulatory, and QA
03
Response to Questions (RTQ)
Regulatory & CMC · Workflow
Turn the authority's question letter into a response where every question and every sub-part is answered, evidenced, and reconciled against your filed dossier and everything you have already told them.
Manual effort today
Two weeks of parallel drafting across functions
04
Regulatory Designation Application
Regulatory & CMC · Workflow
Turn your evidence, your indication and the pathway you're chasing into an argument mapped one-to-one against the statute — with every criterion marked met, partially met or not met, and the gaps named.
Manual effort today
Weeks assembling an argument from memory of what the agency wants, then discovering at review that a criterion was asserted rather than evidenced
05
Technical Due Diligence & Vendor Assessment
Business Development · Workflow
Turn a vendor's quality records, technical package, capacity claims, and financial profile into a structured, evidence-graded due-diligence assessment — scored, gap-flagged, and ready for the deal team or sourcing committee in an afternoon, not a procurement cycle.
Manual effort today
15–30 hours across BD, technical SMEs, and quality
06
Clinical / IMP Supply Plan
Supply Chain · Workflow
Turn your protocol, demand assumptions, and packaging data into a complete clinical / IMP supply plan — demand forecast, supply strategy, coverage and expiry, distribution and cold-chain, and risk/contingency — in an afternoon, not weeks.
Manual effort today
30–60 hours across clinical supply and QA building demand models, coverage tables, and distribution plans by hand
07
Analytical Development Plan Author
Analytical Development · Author
Authors a cGMP-compliant Analytical Development Plan through a single-agent, two-task workflow.
Estimated time saved
~20–35 hrs per ADP document
08
Comparability Plan Author
Tech Transfer · Author
Authors a GMP-compliant, ICH Q5E-aligned Comparability Plan — the governing document that defines the scope, rationale, study design, analytical testing panel, acceptance criteria, and risk assessment approach for a proposed or realized manufacturing process, analytical method, facility, scale, or site change.
Estimated time saved
~20–35 hrs per CP document
A day in the life
The same work, without the assembly.
Your experts still make every call. Sofie gathers the evidence, drafts in your format and marks what is missing.
Preparing an IND
Sections drafted from the science you already have
- Before
- A small team writes CMC sections at night, around the development work itself.
- With Sofie
- Orchestrations draft each section from development reports and batch data, with a review point before anything moves.
Choosing a CDMO
Due diligence that compares like with like
- Before
- Vendor responses of uneven scope are scored inconsistently across reviewers.
- With Sofie
- Sofie scores each vendor against the same criteria, with the evidence for each score and the FDA inspection history attached.
Partner updates
Nothing lost between you and your CDMO
- Before
- Batch data, deviations and decisions arrive by email and live in several inboxes.
- With Sofie
- A program workspace keeps the partner's documents, meetings and your decisions together, and Sofie answers from all of it.
“We believe that TransferAI is the best partner to bring the power of agentic AI to support our regulatory efforts around CLD-401.”
The platform behind it
Part of one connected platform
Orchestrations
Specialized agents coordinated across multi-step work, with human review points.
Regulatory Intelligence
Nine authorities, cited and monitored every day.
Workspaces
Every program, site and client, with its files, people and history in one place.
Research & Chat
Deep research across your files and the web, every claim cited.
Start with one workflow.
Measure it. Then expand.
In a working session we choose a priority workflow, define your standards and review points, and agree how to measure speed, quality and capacity. Then you evaluate Sofie's work before deciding whether to expand.