The transition from early phase to late phase development is a critical point that sets the course of your product’s future. The foundation of a successful scale-up is a thorough understanding of the critical factors that influence product performance. A comprehensive understanding of formulation development and optimization is integrated with analytical validation expertise to ensure scale up goes smoothly. Our process engineers work hand-in-hand with our pharmaceutics and manufacturing teams to design experiments that lead to a commercializable manufacturing process.

Pharmatek Offers:

• Methods Validation
• Formulation & Process Optimization
• Process Scale Up & Validation
• Stability Storage & Testing

Focused on niche products and orphan indications, Pharmatek’s late phase manufacturing capabilities cover a wide range of oral dosage forms, including:

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Capsules

• Solid & Liquid Filled
• Direct Blend
• Granulation (Wet, Dry, Fluid Bed)
• Solid Dispersion
• Semi-Solids (SEDDS)
• Lipid (Emulsions/Suspensions)
• Bead/Multiparticulate

Tablets

• Direct Compression
• Granulation (Wet, Dry, Fluid Bed)
• Coated: Seal & Functional
• Extended Release
• Immediate Release
• Matrix
• Orally Dissolving
• Complexation