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Evaluation of GMP compliance to International Regulatory Standards, covering the manufacture of Non-sterile formulations, such as tablets, capsules, creams, ointments, Formulations and API's to face Quality Audits such as WHO, USFDA, EDQM, MHRA, FDA etc. |
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IPM performs both initial qualification audits to approve a new supplier and on-going audits to meet the requirements of your supplier management program. |
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based on USFDA, MHRA, WHO and ICH norms
- Preparation Of Site Master File
- Master Validation Plan
- Standard Operating Procedures
- Master Formula Records
- Batch Manufacturing Records etc.
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Regulatory Compliance: API and Formulation |
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DMF preparations and review for regulated agencies like USFDA, MHLW, MHRA, HEALTH CANADA, EDQM and other EU agencies and semi-regulated agencies |
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Dossiers preparation and review of regulatory markets (US, Europe, Japan, Canada, etc) as well as for semi regulatory markets. |
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Handling deficiencies raised by regulatory agency |
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Amendments and annual updates of current DMFs |
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Revision of current CEPs |
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Expert report (QOS) preparation |
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Handling queries of other EU agencies with reference to MAA |
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Specific areas like polymorphism, genotoxicity etc. |
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