Process documentation
Batch records, process descriptions, and development reports, written to submission standard.
The CMC firm built for IND speed.
We deliver the CMC, quality, and regulatory work behind your IND in weeks, not months — process documentation, method validation, GMP readiness, Module 3 technical content.
Built by a team from
What we deliver
The technical work on the critical path to your IND.
Method validation
Analytical method validation strategy and protocols, scoped to your modality and stage.
GMP readiness
Risk assessments, gap analyses, and the quality groundwork for a clean manufacturing campaign.
Module 3 content
IND Module 3 technical sections, assembled and review-ready.
How we work
Three steps, weeks not months.
Scope
An initial call to map your IND timeline, modality, and CMC gaps. We assess fit and return a fixed-scope proposal within a week.
Sprint
Senior CMC specialists deliver the work across a compressed engagement window — no handoffs to juniors.
Handover
Submission-ready deliverables and a debrief. Recurring support available for post-IND supplements and comparability.
Our team
Over 15 years in the biopharmaceutical industry.
A proven track record and deep expertise across the disciplines that move an IND forward.
Preclinical & nonclinical development
Chemistry, manufacturing & controls
Quality assurance & regulatory compliance
FAQ
Common questions.
What modalities do you work on?
We focus on cell and gene therapies — autologous and allogeneic cell products, AAV, LNP, and adjacent advanced therapies. We take on small-molecule and biologics CMC work selectively where the team has a direct fit.
How do you compress the timeline?
Senior specialists working in a focused sprint, with scope locked at the outset and no handoffs between juniors. We don’t promise less work; we promise the work delivered faster by the people who can actually do it.
What does a typical engagement look like?
A fixed-scope sprint defined in the initial proposal, running weeks rather than months, with weekly check-ins and a final debrief. Deliverables are submission-ready and yours to use directly in the IND filing.
How do you handle confidentiality and IP?
Mutual NDA upfront. All work product, data, and deliverables remain your IP. We work in your data room or ours, on your terms.
Who owns the deliverables?
You do. Outright. No retained licences, no derivative-work claims, no usage restrictions.