Manufacturing
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Product development
Formulation development of safe, effective and qualitative veterinary medicinal products: selection of appropriate dosage forms, excipients and container-closure systems.
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Analytical development & method validation
Development of analytical methods to demonstrate the stability of the products and validation of these methods: specificity, linearity, accuracy and robustness.
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Stability studies
Design and execution of stability studies to establish the product’s shelf life and in-use shelf life, as well as maintenance of an adequate ongoing stability programme.
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Process development
Process development and optimisation: from laboratory and pilot scale to production scale batches.
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Regulatory support
Regulatory support throughout the product’s entire life cycle: pre-approval (validation studies, stability studies, etc…) as well as post-approval (preparation of Product Quality Reviews and documentation needed for variations).
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Process validation
Demonstrating the capability of consistently producing a finished product of the required quality.
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Routine manufacturing
Toll manufacture of veterinary medicinal products: parenterals (e.g. injectable solutions), oral liquids, oral powders, complementary feed and collars.