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Consulting Services | ||||||
Regulatory |
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Regulatory strategy development |
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Interface with regulatory agencies | ||||||
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Due diligence | ||||||
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Systems audits | ||||||
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Compliance | ||||||
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Technical evaluation of vendors, service providers |
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Evaluation and audits of manufacturing facilities | ||
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Regulatory submissions – INDs, IMPDs, QOS | ||
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Documentation – SOPs, reports | ||
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Training | ||||
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Drug development process | ||||
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Introduction to regulatory affairs | ||||
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Clinical trial regulations and process – India, US, EU, Canada | ||||
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Overview of ICH and applications to industry | ||||
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Overview of major types of submissions –IND, NDA, ANDA, DMF | ||||
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Introduction to GMPs, GLPs, GCPs and ongoing refresher programs | ||||
| Specializing in customizing interactive programs for various audiences. | |||||
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Documentation | ||||
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Preparation of entire CTAs, INDs | ||||
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Dossier compilation including supporting documents and reports | ||||
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Assembly of briefing packages for regulatory meetings | ||||
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