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INDUSTRIES WE SERVE... |
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Pharmaceuticals |
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Biopharmaceuticals / Biologics / Immunologics / Diagnostics |
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Active Pharmaceutical Ingredients (APIs) / Bulk Drugs |
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Pharmaceutical Excipients / Additives / Adjuncts |
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Medical Devices / Disposables |
REGULATORY AFFAIRS (Click here) |
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PharmAlliance has first-hand knowledge of worldwide pharmaceutical regulations. |
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PharmAlliance provides insight into how the regulatory agencies think and what data they will need |
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to approve specific products. |
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PharmAlliance clarifies regulatory issues, anticipates potential problems, and gets products to |
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approval through the fastest and most direct route possible |
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PharmAlliance has extensive experience in interacting with FDA (USA), TPD (Canada), EMEA, EDQM |
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and EU National Authorities, including MHRA (UK), MCC (South Africa), TGA (Australia), and other |
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regulatory agencies worldwide. |
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PharmAlliance specializes in preparing and handling regulatory submissions for all major world |
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markets. (Click here for details for DMF / EDMF / CEP / COS / ANDA / ANDS / Abridged MAA) |
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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 pre-clinical and clinical |
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research spectrum …. Phase I, II, and III trials as well as bioequivalence studies for European and |
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North American markets |
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PharmAlliance has links with reputed CROs in USA, Canada, Europe (including Eastern Europe), |
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and India. |
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PharmAlliance facilitates access to the comprehensive resources, expertise, and experience of |
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such reputed CROs. |
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PharmAlliance evaluates CROs worldwide and provides expert guidance for selection of CROs |
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and negotiations for outsourcing studies. |
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TRAINING AND EDUCATION (Click here) |
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Regulations, Regulatory Procedures, Strategic planning for Regulatory Affairs : |
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FDA (USA), TPD (Canada), European Union, TGA (Australia), MCC (South Africa), WHO |
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Compliance Management for International Markets |
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Quality Systems, Manufacturing and Control Operations |
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Validation |
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Bioequivalence Studies for Regulatory Submissions |
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Clinical Pharmacokinetics and Protocol Design for Regulatory Submissions |
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Pre-Clinical and Clinical Research and Clinical Trials Management |
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BUSINESS DEVELOPMENT (Click here) |
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PharmAlliance has an extensive information base, and worldwide contacts. |
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PharmAlliance provides insight into worldwide market opportunities for your organization. |
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PharmAlliance assists with Patent Screening, Product/Market Selection, Strategy Development, |
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Strategic Planning for International Market Development. |
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PharmAlliance can help you gain entry into the profitable, multi-billion dollar North American and |
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European markets and the rapidly growing markets of Asia and Latin America. |
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PharmAlliance can help you in setting up of contract manufacturing and product licensing |
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arrangements. |
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Full Service…Interactive Process… Successful Projects |
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