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Setting up systems to meet the requirements of different regulatory
agencies -- USFDA, TGA, EDQM, WHO GMP etc, |
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Filing CTDs and eCTDs for US, Europe, Canada, Australia or any other country |
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Analytical validations and stability studies |
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Third party audits for qualifying vendors and surveillance audits |
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Compliance audits within the company |
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Training and staffing |
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LIMS (lab information management systems) |
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Enterprise Resource Planning (ERP) |
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Business process improvement using lean sigma methodologies |
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BI (business intelligence) solutions in the entire pharma spectrum from development to launch |
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Help in transforming work culture leading to higher yields, quality and consistency |