Our team of dedicated project managers and of subject-matter-experts have successfully developed a wide range of products and dosage forms, supporting diverse regulatory approvals (IND, NDA, 505 (b) (2), ANDA). Groupe PARIMA can meet your product development and site-transfer needs based on the status of your project. Our experts in formulation development, scale-up process, analytical method development & validation and packaging, will see your product through initial development phases until completion of process validation.
Expertise in formulation development
Liquids, Suspensions, Creams, Lotions, Gels, Ointments, Pastes, handling of low flash point products and processes
Different stages of activities
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Basic formulation
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De novo formulation
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Reverse engineering
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Equivalence to reference drug products
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Raw material sourcing for cGMP Production
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Effectiveness and stability of formulations
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Identification of critical characteristics
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Selection of packaging components
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Process development
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Laboratory, pilot, and cGMP clinical trial materials Commercial scale cGMP
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Development and optimization using QbD
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Documentation and reporting to support regulatory filings
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Development of packaging process (primary and secondary)
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Stability and transportation studies
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Supply of clinical and pre-clinical batches
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Small scale productions for pre-clinical studies
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Supply of cGMP clinical material (Phases I-III)
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Excess product stored on-site for future studies
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Stability studies
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Customized packaging and labeling
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Commercial validation
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Artwork preparation
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Sourcing of all sales packaging material
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Complete manufacturing, holding, packaging and cleaning validation
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Stability studies
