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Thursday, 28th of November, 2024 |
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 We offer focused and dedicated support to the Active Pharmaceutical Ingredients (API) and Formulation manufacturers to improve their operations and stay compliant in a challenging regulatory environment. In addition to auditing services, weal so provide solutions in the domains of ERP, Business Intelligence, Training & staffing to enhance business opportunities in rapidly growing Pharmaceutical and Biotech Industry. Our team of professionals has vast experience and proven track record in offering consulting for achieving ISO, WHOGMP, CEP (COS), USFDA and various regulatory certifications. |
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Experienced professionals who headed the Production, QA, QC, Regulatory and R&D departments in API and formulations. |
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End-to-End support in managing Regulatory compliance right from setting up the systems, carrying out the audits, helping companies in carrying out facility qualifications, process and analytical validations, filings and facing the agency audits |
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Shop floor process improvements using lean sigma methodologies, people involvement and score carding to achieve manufacturing excellence |
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Delivers best in-class services to our clients while exceeding their expectations. |
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Maintains complete confidentiality and security |
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Helping companies to set up systems to meet the requirements of various regulatory bodies like USFDA, TGA, ISO, EDQM, WHO GMP etc. |
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Filing DMFs for Europe, US, Canada 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, Enterprise Resource Planning (ERP) |
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(Business Intelligence) Business process improvement using lean sigma methodologies and consolidation of gains through score carding |
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Help in transforming work culture leading to higher yields, quality and consistency |
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Annual Maintenance Contract ( Quality systems & Regulatory compliance) |
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 The Facilities Consulting team led by Mr. Selvakumar and other professionals having years of practical and managerial experience in implementation of ISO, GMP, GLP, GDP and GCP for the pharmaceutical and related industries in both large multinational organisations and small entrepreneurial companies.
Our Quality Advisors and Consultants are person-ally involved with each project to meet your specific quality and Regulatory requirements. |
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