Formulation Development

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

formulation development - banner

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..

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strategic-excipient-selection

Strategic excipient selection

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

02
Continuity across stages

Controlled rheology & stability

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

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Process Development and Scale up

Process development & scale‑up

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

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control strategy definition

Control strategy definition

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

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project manager

Timeline & clinical trial readiness

Pre‑formulation outputs are aligned with clinical supply goals to support stage readiness and key regulatory milestones.

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Manufacturing tank cream

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.

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
Blog
2026/07/03
Topical 101: A Guide to Complex Dermatology Formulation Development
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
Blog
2026/07/03
Topical 101: A Guide to Complex Dermatology Formulation Development

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.