Process development
We design robust, scalable, reproducible processes from the ground up — defining a target product profile, locking critical process parameters, and stress-testing the process so it survives scale-up and regulatory scrutiny alike.
Services
One partner, the whole lifecycle.
Engage Solua for a single phase or the full journey from discovery to commercial launch. Whatever the scope, your program stays inside one integrated quality system — no handoffs, no lost context, no surprises at inspection.
cGMP clinical & commercial manufacturing
Segregated, single-use GMP suites for autologous and allogeneic supply — from first-in-human batches through validated commercial production, with the capacity and quality systems to grow alongside your program.
Tech transfer & pre-approval readiness
Whether you're moving a process in from your bench, between our sites, or out to a commercial network, we run disciplined, documented transfers — and prepare your program for the scrutiny of a pre-licensing inspection.
Regulatory strategy & CMC
CMC strategy, module authoring and agency interactions that keep your filing on the front foot. Our regulatory scientists translate process and analytical data into a coherent, defensible regulatory narrative.
Bioassay & analytical development
Potency, identity, purity and safety methods developed, qualified and validated for release. We build mechanism-relevant assays that hold up under regulatory review and travel cleanly through tech transfer.
Tissue sourcing & acquisition support
Qualified starting-material acquisition with end-to-end chain of identity — from donor and collection-site qualification through logistics to the manufacturing floor, so the right material arrives at the right time, verifiably.
How we engage
A clear path from first call to first batch.
No black boxes. Every program follows a transparent sequence with defined deliverables and decision gates.
Scoping & feasibility
We assess your candidate, define a target product profile and agree the New Product Introduction plan — including timelines, deliverables and risk.
Process & analytical development
Our scientists build a robust, scalable process and the methods to measure it, characterizing the critical parameters that define quality.
GMP manufacturing
Clinical supply in segregated single-use suites, scaling with your trials and held to the same quality system from day one.
Validation & commercial launch
Process performance qualification, pre-approval inspection readiness and resilient commercial supply at launch and beyond.
Quality & compliance
One quality system, end to end.
A program shouldn't lose its quality history every time it changes hands. With Solua it doesn't.
Every phase — development through commercial — operates inside a single, harmonized quality management system. That continuity is what lets data, deviations and learnings flow forward instead of being rebuilt at every stage, and it's why our partners walk into inspections prepared rather than anxious.
- Harmonized QMS spanning development to commercial
- 19 regulatory and pre-licensing inspections passed
- Data integrity by design across the Coherra™ platform
- Risk-based, phase-appropriate controls
- Inspection readiness as a continuous discipline
Let's scope your program.
Send us your modality, stage and timeline. We'll come back with a credible plan and an honest view of what it takes.