Formulation strategy built on QBD, not guesswork
Pharmaceutical formulation development consulting for NDA and ANDA submissions. CMC expertise designed for the rigor of advanced markets.
Most consultants promise approvals. We frame the science that earns them.
Go beyond simple drug development with formulation design built to withstand regulatory scrutiny. We map your topical candidate to a development path that anticipates reviewer questions rather than answering them later.
Eleven submission areas, one standard.
Every NDA and ANDA we touch is built on Quality by Design, with a CMC strategy that anticipates reviewer questions before they're asked.
100%
QbD-driven design
No guesswork. Each formulation is planned from target profile through CMC.
11+
CMC sections covered
From drug substance to container closure, we address every regulatory module.
100%
Advanced-market focus
Submissions built to meet the rigor of the US, EU, and other regulated markets.
1×
Right-first-time intent
We aim for a complete, defensible package in the first submission.
Regulatory work that holds.
Clients rely on this consultancy for NDA and ANDA formulation design that brings clarity to complex CMC questions and moves submissions forward.
As a new consultancy, they brought a surprisingly sharp focus to our topical ANDA strategy. The CMC guidance kept our submission on track.
Project Lead, Formulation R&D
Generic pharmaceutical development team
Their Quality by Design approach gave us a clear path to address our formulation challenges. Communication was direct and technically grounded.
Senior Scientist, Product Development
Topical drug product developer
We appreciated the practical, regulatory-first perspective on our NDA. It clarified what the advanced market submission actually needed.
Regulatory Affairs Consultant
Independent pharma regulatory support
The formulation roadmap, stage by stage
Walk through the formulation development process and see what you can expect at each stage.
Reach out with your target product profile. From there you receive a structured development plan covering the formulation approach, CMC pathway, and the key deliverables for your submission.
Facing a topical formulation that stalled?
Bring the challenge to the first consultation. We'll assess feasibility and map a QbD-driven path to a submission-ready CMC strategy, no matter how complex.