Formulation Development

We develop non‑sterile formulations designed for consistent performance and reliable GMP manufacturing.

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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

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

Deformulation

Reformulation of existing drug products to support reformulation via the 505(b)(2) pathway and development of comparable formulations under 505(j).

optimization

Optimization

Strengthen an existing formulation by optimizing excipients and process variables using DoE to improve stability, manufacturability, and batch‑to‑batch consistency.

Scale up

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

Strategic excipient selection

Select excipients based on functionality, API compatibility, and target product performance.

02
Controllev rheology and stability

Controlled rheology & stability

Optimize viscosity and physical stability to maintain consistent performance through shelf life.

03
Process Development and Scale up

Process development & scale‑up

Define process parameters that transfer to GMP equipment with predictable results.

04
control strategy definition

Control strategy definition

Set in‑process controls and acceptance criteria to support validation readiness and ongoing consistency.

05
Timeline and clinical trial readiness

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 (2)

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.

White papers
2026/07/06
How Drug Product Formulation Works: Topical, Oral, and Nasal Liquid and Semi-Solid Dosage Forms
White papers
2026/07/03
How Early API Characterization Can Reduce Formulation and Scale-up Risks
White papers
2026/07/06
How Drug Product Formulation Works: Topical, Oral, and Nasal Liquid and Semi-Solid Dosage Forms
White papers
2026/07/03
How Early API Characterization Can Reduce Formulation and Scale-up Risks

Contact us

Have a formulation project in progress?

Partner with Groupe PARIMA to develop and transfer non‑sterile formulations using QbD, fit‑for‑purpose analytics, and a control strategy designed for reliable GMP manufacturing.