Technology Verticals
Development, Clinical Trials, Validation and Launch.Active Ingredient
Formulation
Sterile Drugs, traditional oral solids and novel dosage forms
Cell Therapy
e.g., stem cells, CHO cells, bacterial and mammalian
Medical Devices
Biological Active Ingredients:
Active Pharmaceutical Ingredient (API) is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, used in the synthesis by fermentation. Confidential detailed information about facilities, processes, or articles used in the cell culture bio-manufacturing, bio separation, down stream processing, packaging, and storing of one or more human drugs.
Clinical studies
An clinical study (PK) is a limited clinical investigation of a drug in development. which typically:
- enrolls a small number of subjects;
- is used to evaluate the drug design concept with respect to initial clinical safety and functionality;
- may guide drug modifications PK/PD Studies
Study of the Pharmacokinetics (PK) and Pharmacodynamics(PD) of the drug in humans
–PK: what the body does to the drug (Absorption, Distribution, Metabolism, Excretion)
–PD: what the drug does to the body•PK and PD profiles of the drug are influenced by physicochemical properties of the drug, product/formulation, administration route, patient’s intrinsic and extrinsic factors (e.g., organ dysfunction, diseases, concomitant medications, food)
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For all your healthcare products contact our expert team members providing complete CMC [Chemistry Manufacturing and Quality Control] technical support.