See your CMC portfolio like the mountain it is.
Summit is portfolio intelligence for CMC leaders — a single, honest view of risk, effort, time, and resource constraints across every program. So decisions get made on the data, not the loudest voice in the room.
Built for clinical-stage teams managing 2–15 active CMC programs.
Why Summit
One workspace. Every program. In the order the work actually flows.
Plans, risk, control strategies, decisions, and lessons — one workspace, structured the way CMC work actually flows.
From QTPP to development plan
Where every CMC program begins.
From Target Product Profile to a sequenced CMC plan that reflects your molecule, modality, and regulatory pathway. Structured from day one.
Risk and control strategy, connected
Scored, traceable, always current.
Every CQA carries its criticality score. Every CPP carries its risk rating. Summit keeps the connections live — scored, traceable, and always current.
Portfolio governance, always defensible
Walk in with the current picture, every time.
Plans, risk frameworks, and decisions in one place — so leadership time is spent deciding, not reconstructing.
Knowledge that compounds
Tagged, searchable, reusable.
Every decision made, every risk rationale written, every lesson learned — tagged, searchable, and available to the next program that needs it.
The problem
CMC program development is complex by nature. It deserves infrastructure built for that complexity.
QTPPs deserve more than a Word document.
Translating a Target Product Profile into a structured, realistic CMC development plan is where Summit begins.
Critical knowledge belongs in a system.
Risk assessments, control strategy rationale, and decisions are too important to live only in slides and institutional memory. Summit curates that expertise so it compounds across every program.
Lessons learned should actually be learned.
Most organisations capture lessons at the end of a program and file them somewhere they're never found. Summit keeps them alive — searchable, tagged to context, and surfaced when the next program needs them.
Governance should reflect current reality.
When plans, risk, and decisions live in one place, portfolio review becomes forward-looking — not a reconciliation exercise.
New — Knowledge Base
The decisions your team made last year should inform the program you're starting today.
Summit's Knowledge Base is a searchable library of past decisions, risk rationale, and lessons — each tagged to the program, phase, and context where they originated. When a new program lead asks "have we seen this aggregation risk before?" — the answer is in Summit, not in someone's inbox.
- Search across every program for relevant precedent before repeating costly experiments.
- Surface prior risk rationale when the same CQA appears in a new molecule.
- Give new team members immediate access to the thinking behind past decisions — not just the outcomes.
"The institutional knowledge your organisation has already paid for — finally structured and findable."
New — Completed Programs
A program that closes shouldn't take its lessons with it.
Completed Programs preserves the full Program Summary Book for every program Summit has governed — intact, readable, and mineable.
Archive
The complete record of every chapter — overview, timeline, risk framework, decisions, team — exactly as it stood at close.
Precedent
Search across completed programs to find prior art before you start. What risks did we score highest on a Phase 2 mAb? What pivots did we make when PPQ slipped? What did the control strategy look like at IND?
"Your most expensive lessons are already paid for. Summit makes sure they earn interest."
The hero workflow
CPP-to-CQA relationships, scored and traceable across every program.
Every Critical Quality Attribute is shaped by a network of Critical Process Parameters. Summit's Interaction Map scores and maintains every connection — so the relationship between process performance and product quality is always explicit, always current, and always traceable across the entire portfolio.
- Maintain a scored, traceable map of every CPP-to-CQA relationship across all programs.
- Identify where the control strategy requires strengthening before it becomes a regulatory question.
- Give every CMC team member — and every governance reviewer — the same current picture.
CPP-01 drives a criticality-9 CQA with RPN 100 (S 10 × O 10 × D low). With detectability currently weak, residual risk cannot be caught downstream.
→ Propose a characterization DoE for CPP-01 this quarter and add an in-process control to lift detectability before Phase 3 — this single action collapses the project's largest control-strategy gap.
Illustrative view — one CQA and its highest-scoring CPP connections.
What's in Summit
Three essential functions. Safe delivery, guaranteed.
Summit covers the three essential functions in CMC — defining, producing, and learning — so every program is delivered safely to its planned destination.
Define & Plan
Shape the program, the control strategy, and the Plan of Action before execution begins.
Produce & Govern
Run the live execution queue with risks, decisions, teams, and governance always in view.
Analyze & Learn
Read portfolio health, surface collisions, and compound knowledge across every completed program.
How Summit works
From target product profile to governed portfolio.
From QTPP to structured development plan.
Summit turns your QTPP into a sequenced plan — activities, dependencies, and risk assumptions explicit from day one.
Control strategy and risk, connected.
CQAs, CPPs, risk scores, and rationale are built and maintained together — traceable and current.
Portfolio decisions on current information.
Every plan, risk framework, and decision in one place. Governance becomes evidence-based, not a prep exercise.
From CMC, for CMC.
The founders are from CMC, looking to design solutions for CMC.
Help shape what gets built.
A brief, confidential conversation. No sales pitch. Helps us prioritize what we build.