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 for reliable scale-up and consistent commercial manufacturing.
Formulation development establishes product performance, stability, and manufacturability. Groupe PARIMA develops liquid, suspension, and semi-solid formulations using QbD principles to define product objectives and link CQAs with excipient selection, process parameters, and control strategies that support scale-up and validation.
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 product development
Design a new formulation around your API and target product profile, with excipient selection and process establishment built for GMP manufacturing.
Product reformulation
We characterize existing drug products and develop reformulation strategies to support product optimization, lifecycle management, and differentiated development programs, including applicable 505(b)(2) and 505(j) pathways.
Product optimization
Strengthen an existing formulation by optimizing excipients and process variables using DoE to improve stability, manufacturability, and batch‑to‑batch consistency.
Product Scale-UP
Studies supporting process scale‑up and equipment adaptation to ensure successful technology transfer across production.
Built for performance and scale up
We develop non‑sterile liquids, suspensions, and semi‑solids using QbD to define CQAs, critical process parameters, and a lifecycle control strategies that support robust scale-up and commercial manufacturing..
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 incorporate manufacturing requirements from the outset to support scalable, robust, and reproducible processes.
Resources
Explore practical guidance on non‑sterile formulation development, scale‑up, and control strategy.