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| PharmAlliance is an independent, professional service organization, dedicated to serving the |
| pharmaceutical, biopharmaceutical, API (active pharmaceutical ingredient), medical device, and allied |
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| PharmAlliance was established in January, 2000, and has an impressive track record as a full-service, yet |
| a flexible and responsive organization for providing complete, comprehensive and highly specialized |
| consulting services . |
| FACILITY DESIGN AND DEVELOPMENT / PROJECT SERVICES |
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| PharmAlliance specializes in conceptualizing and designing of state-of-the-art |
| manufacturing, testing, and R&D facilities conforming to the most stringent |
| international cGXP (GMP, GLP, GCP) norms .....Read More |
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| INTERNATIONAL REGULATORY AFFAIRS |
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| PharmAlliance specializes in preparing and handling regulatory submissions for |
| all major regulatory agencies, such as FDA (USA), TPD (Canada), EMEA, EDQM, |
| EU National Authorities including MHRA (UK), BfARM (Germany), as also TGA |
| (Australia), MCC (South Africa), and others .....Read More |
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| QUALITY SYSTEMS |
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| PharmAlliance specializes in developing and implementing quality systems |
| (manufacturing / control systems, SOPs and related documentation) to achieve |
| full cGXP compliance .....Read More |
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| cGXP AND DUE DILIGENCE AUDITS |
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| PharmAlliance conducts cGXP audits of clients' own facilities to assess |
| compliance, or, cGXP as well as due diligence audits of contract or outsourcing |
| facilities on behalf of clients to monitor them for compliance .....Read More |
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| SUPPORT SERVICES FOR PRE-CLINICAL, CLINICAL AND BIOEQUIVALENCE STUDIES |
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| PharmAlliance provides support services for studies across the entire preclinical |
| and clinical research spectrum …. Phase I, II, and III trials as well as |
| bioequivalence studies for all major world regions, including Europe and North |
| America ...Read More |
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| TRAINING AND EDUCATION |
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| PharmAlliance specializes in developing and conducting training programs, |
| workshops, and seminars for clients, which are unique to their specific |
| needs ...Read More |
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| BUSINESS DEVELOPMENT |
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| PharmAlliance assists in strategic planning for business development, |
| (international patent consulting, product /market selection, sponsor identification, |
| feasibility studies) .....Read More |
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| OUTSOURCING ARRANGEMENTS - CRAMS |
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| PharmAlliance assists clients in locating contract manufacturing, testing, or |
| research facilities or joint venture partners for outsourcing in the rapidly |
| developing Asian markets, and conducts due diligence as well as cGXP audits |
| of potential collaborators on behalf of clients .....Read More |
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| Full Service… Interactive Process… Successful Projects |
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