ZEN PHARMATECH LLC
Summary
Research and Development, Technology Transfers, Manufacturing, Engineering, Calibration services, Quality/Regulatory services, Outsourcing, Supply Chain
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Description
Proven track record to develop and launch numerous new products from bench scale to full scale commercial batches. We can offer wide range of services in product development cycle, such as: -Formulation Development: Develop ethical, Rx (generic) and over-the-counter formulations like tablets, capsules, liquids and topical products -Process development: scale up and validation of pharmaceutical dosage forms -Product and Technology assessments: identify CMO / site capable to support commercial manufacturing, cGMP status etc -Due diligence and auditing: dossier review / gap analysis etc. -Outsourcing and Supply Chain: CMO selection -Technology transfers / Site transfers: identify and establish cross functional teams for smooth transition of technology a -Operational excellence -Engineering Support: Design of manufacturing equipment/facilities and quality systems like calibrations, qualifications etc. -Quality/Regulatory services
