Formulation Development
We develop non‑sterile formulations designed for consistent performance and reliable GMP manufacturing.
Formulations designed for GMP
We design robust non‑sterile dosage forms that translate into consistent manufacturing.
Formulation development sets product performance, stability, and manufacturability. Groupe PARIMA develops liquid, suspension, and semi‑solid formulations using QbD to predefine objectives and link critical quality attributes, excipient selection, process parameters, and a lifecycle control strategy that supports scale‑up and validation readiness.
We turn formulation targets into manufacturable liquids, suspensions, and semi‑solids with defined CQAs and a control strategy.
Expertise in Formulation
We develop non‑sterile products with a QbD approach that defines CQAs, process parameters, and a control strategy for scale‑up and validation readiness.
De novo development
Design a new formulation around your API and target product profile, with excipient selection and process establishment built for GMP manufacturing.
Deformulation
Reformulation of existing drug products to support reformulation via the 505(b)(2) pathway and development of comparable formulations under 505(j).
Optimization
Strengthen an existing formulation by optimizing excipients and process variables using DoE to improve stability, manufacturability, and batch‑to‑batch consistency.
Scale-UP
Studies supporting process scale‑up and equipment adaptation to ensure successful technology transfer across production.
Built for performance and transfer
We develop non‑sterile liquids, suspensions, and semi‑solids using QbD to define CQAs, critical process parameters, and a lifecycle control strategy.
01
Strategic Excipient Selection
Select excipients based on functionality, API compatibility, and target product performance.
02
Controlled Rheology & Stability
Optimize viscosity and physical stability to maintain consistent performance through shelf life.
03
Process Development & Scale‑Up
Define process parameters that transfer to GMP equipment with predictable results.
04
Control Strategy Definition
Set in‑process controls and acceptance criteria to support validation readiness and ongoing consistency.
05
Timeline & Clinical Trial Readiness
Pre‑formulation outputs are aligned with clinical supply goals to support stage readiness and key regulatory milestones.
06
Early Manufacturing Insights
Development decisions integrate manufacturing considerations early to support scalable processes and smooth technology transfer.
Resources
Explore practical guidance on non‑sterile formulation development, scale‑up, and control strategy.