Formulation design with a clear path to approval
A structured development process built on QbD and CMC expertise, designed to get your topical formulation submission-ready.
We start by mapping your API, target profile, and intended market. That one hour shapes the entire QbD strategy we build around your molecule.
A formulation path anchored in Quality by Design
We assess excipient compatibility and API characteristics early, so you avoid costly reformulation loops before development work begins.
Documentation that holds up through review, every section, every time.
We define the QTPP up front, naming the quality attributes your product must hit. That target guides every later decision, keeping the file consistent.
Deliverables built for submission success
Every formulation package we deliver is built around QBD principles and CMC readiness, so your NDA or ANDA submission carries less regulatory risk.
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Deliverable tiers
Each package is aligns with submission goals: feasibility, optimization, or full CMC documentation.
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QBD-aligned designs
Every formulation design links critical material attributes to the final product's target profile.
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Market standards
We prepare for both NDA and ANDA pathways, following advanced-market regulatory expectations.
1
Point of contact
You work directly with the formulation scientist leading the project from design to documentation.
Don't start with a formulation. Start with the questions regulators will ask.
A product is never submission-ready until the formulation and the CMC package hold up under review. That scrutiny starts with a short, direct consultation about your molecule and your target market.