Start your formulation development with a CMC strategy that holds up
Strategic topical formulation design for NDA and ANDA submissions. QBD-driven R&D built for the rigor of advanced markets.
Your first ANDA draft should raise questions. Our job is to answer them.
We define the critical quality attributes and a risk-based design space before you commit to a formulation path, not after.
A generic topical formulation file, built for your ANDA submission.
A structured build of your generic topical formula, mapping each excipient and process step to the quality target from day one.
Consulting that fits your project phase
Clear engagement options for formulation design and CMC support. Pick the scope that matches your development stage.
Formulation Review
Quote
per projectA focused assessment of your current formulation approach with actionable recommendations.
Formulation strategy assessment
QBD gap analysis
Risk-based priority list
One working session
Development Partner
Quote
per projectEnd-to-end formulation design support from early prototypes through submission-ready documentation.
Prototype design and screening
CMC documentation support
NDA or ANDA submission guidance
Regular progress reviews
Direct consultant access
CMC Advisory
Quote
retainerOngoing regulatory and CMC guidance for teams navigating complex submission requirements.
Ongoing CMC consultation
Submission readiness checks
Deficiency response support
Priority email access
Need a custom scope?
Contact for a tailored engagement
Formulation science that survives review.
Every engagement is measured the same way we measure success: a submission that clears regulatory scrutiny. Here's how that focus shows up for clients.
We brought a sticky topical challenge to this consultancy and left with a design space we could defend. The CMC section wrote itself after that.
Liz Wen
Formulation Lead
The QbD approach replaced our guesswork with data. Our ANDA package moved forward with fewer queries than anything we'd filed before.
Client B
Regulatory Affairs Manager
Critical formulation problems are the only kind we hand off. The risk assessment was clear, the mitigations were realistic, and approval came without surprises.
Client C
Head of Product Development
Ready to move your formulation from concept to submission?
Kick off your project with a formulation strategy built on QBD and CMC rigor. We respond within one business day.