Propharmex Inc

Propharmex Inc. was founded as a specialized pharmaceutical company to provide niche, complex generics, and specialty products to the global market. Headquartered in Canada and with a State of the art Pharmaceutical development laboratory in Hyderabad, India, we provide end-to-end and tailor-made services in the Pharmaceutical Industry right from Product Identification and Conceptualization, Regulatory pathway, Pharmaceutical Development, Manufacturing, Regulatory submission, and Product life Cycle management. Our experience in developing complex generics for various therapeutic areas across different dosage forms, helps our partners conceptualize their novel ideas into well worked out proof of concepts supported by strong scientific and regulatory rationale. With our global network, we help you identify the right contract manufacturer with the right working capacities and quality systems. We strive to be the key control point to ensure quality and continuous supply. We are confident of adding value to your business and being a part of your success story. Services: Product Development: Global generics and differentiated products Analytical Services: AMD, AMV, Nitrosamines (API / FP), Extractable leachables, IVRT studies Regulatory Services: Dossier Due Diligence, Dossier compilation, and submissions for US, CA, EU, and other global markets. BA-BE Studies: Study Design and Coordinate (monitor) the Study Execution. Contract Manufacturing: Liaising third-party manufacturing and Technology Transfers. Trouble Shooting and Product Life Cycle Management Business Development: Licensing and sourcing of commercial supplies. Canadian Market: Specialized in NPN Product filings, Regulatory submissions, MDAL Applications, 3 PL services