Brief us on your next formulation
We design submission-ready topical formulations for NDA and ANDA programs, built on QBD and CMC rigor for advanced markets.
What does strategic topical formulation design actually look like?
It starts with Quality by Design, not guesswork. We shape every formula around the CMC data your NDA or ANDA submission needs, so the science carries the regulatory story from day one.
Formulation leadership grounded in QBD
Our consultancy pairs hands-on formulation experience with deep CMC knowledge, so your NDA or ANDA submission is built on science that regulators trust.
Tushar Jadhav
Principal Formulation Consultant
Leads topical formulation strategy with hands-on R&D experience across NDA and ANDA programs, integrating QBD principles into every development phase.
Pratima
Projects
Controls projects timelines and contracts, aligning development outputs with the customer expectations ensuring advanced market regulators.
Built for advanced markets.
Formulation expertise recognized through a disciplined approach to Quality by Design, CMC strategy, and submission-ready documentation for NDA and ANDA pathways.
The CMC strategy reflected a clear command of QBD principles, giving our regulatory team confidence in the submission package.
Name withheld
ANDA development program, CMC
A focused approach to topical formulation design that addressed our critical quality attributes before they became issues.
Name withheld
Formulation manager, generic dermatology portfolio
The QBD framework presented was rigorous and practical. It streamlined our path to a submission-ready ANDA package.
Name withheld
CMC director, advanced markets
Formulation success built on QBD, and experience not guesswork
Every topical formulation we design follows the same disciplined path: a QBD framework, a CMC strategy, and a focus on submission success. That is how we turn critical challenges into regulatory wins.
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Submission pathways
NDA and ANDA, each with a clear regulatory route to advanced markets.
100%
QBD-driven designs
Every formulation starts with Quality by Design, not trial and error.
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Focus: topical delivery
Dedicated expertise in topical formulation development and CMC.
A formulation development roadmap for your next submission.
You identify the critical challenge. We map the QBD framework and CMC strategy behind a submission-ready formulation dossier.