Development
Built for Speed and Compliance
End-to-end
Formulation → Methods → IND/CMC → GMP batches
U.S.-based labs
FDA-registered, cGMP operations; global submission experience
Right-size partners
Senior scientist access, fast starts, small-to-mid scale expertise
Services at a Glance
Formulation Development
Pre-formulation, solubility/bioavailability strategies
Solid oral, liquid, and polymer-enabled delivery (e.g., controlled release)
Analytical Development & QC
Method development and validation (ICH Q2)
Release/stability (ICH Q1A), impurity profiling, dissolution
Regulatory & CMC
IND/Module 3 authoring support, specification setting
Process/method validation packages; agency Q&A support
GMP Scale-Up & Clinical Supply
Tech transfer, batch records, pilot-to-clinical batches
Phase-appropriate controls, continuous improvement/QbD
The Process
01
Assess –
Gap review, target product profile, risk map
02
Design –
Route/formulation strategy, plan, acceptance criteria
03
Prove –
Methods, prototypes, stability, specs
04
Transfer –
GMP docs, batch records, validation plans
05
Supply –
Clinical lots, ongoing QC, change control
