APSL provides end-to-end services in drug product development framework traverse all the way from pre-formulation and formulation development, technology transfer, through GMP clinical trials and commercial production for injectable dosage forms with a focus on quality, speed, and cost-efficiency.
Our services for injectable formulations include performing solubility studies, composition design and optimization, process design and optimization, conducting accelerated and prototype stability studies as per the guidelines, hold time and compatibility studies, reconstitution studies and dilution studies, product container closure system identification, selection and finalization, but not limited to. We also provide services for scale-up activities and manufacturing of clinical batches in a current good manufacturing practice (cGMP) environment. The lifecycle of the drug product is given below
Solubility enhance studies include
Services across the product lifecycle
Regulatory inspected lab and manufacturing facilities
Experience in delivering various injectable dosage forms
Expertise in overcoming technical challenges
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