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Scientific and Regulatory Consulting
Overview |
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Covance has the experience and expertise to provide all regulatory support services required throughout the drug development process.
Clinical Trial Support
- Complete Clinical Trials Application (CTA) service (preparation and submission)*
- Investigator Brochure (IB) and Investigational Medicinal Product Dossier (IMPD) preparation*
- Investigational New Drug (IND) preparation*
- IMPD and IND conversions
- Standalone review of Sponsor-prepared documents.
Drug Marketing/Product License Support
- Drug Marketing/Product License Support
- Nonclinical overviews**
- Report tabulations**
- Narrative summaries.**
General Consultancy Support
- Literature reviews
- Preparation of strategy or position papers
- Expert advice/problem solving
- Gap analysis
- Critical review of data (and/or independent, second opinion)
- Inward licensing reviews
- Advice on go/no go decisions
- Preparation of Briefing Books
- Organization of and attendance at meetings with regulatory agencies
- Preparation of study reports/journal manuscripts.
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including CMC input/expertise |
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using in-house or Sponsor-supplied Common Technical Document templates |
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