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is your ideal strategic partner for outsourced pharmaceutical dosage form development and clinical manufacturing.
Cerovene offers comprehensive service capabilities, from product concept development to market launch such as: · R&D and manufacturing of High Potency Products · Pre-Formulation: characterization of drug substances and excipients · Formulation and product feasibility · Formulation development and optimization · Controlled substances (Schedule II, III) · Engineering product formulations/process to fit client facilities/equipment · Technology transfer · Scale-up manufacturing and process validation support · Test methods development and validation for active drug substances and finished products · Interfacing with CROS for bioequivalence and clinical studies · FDA pre-approval and pre-market validation support · Developing regulatory and compliance strategies to optimize success of drug approval by the FDA · Consultation on building R&D Teams and Facilities
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