Mandava Associates has a proven and successful track record in dealing with the FDA for Veterinary Drug approval. Some of the services that are covered under this area but not limited to are:
FDA Veterinary Drugs |
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Chemistry, manufacturing and controls (CMC) |
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Data development and strategy |
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Drug development strategies and assessments |
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Drug Master Files for US and EU |
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Drug establishment registrations and drug product listing |
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Environmental Assessments |
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Post submission support |
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Quality assurance and quality control |
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Regulations interpretation |
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Regulatory management and strategic planning |
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Toxicology, pathology, microbiology and safety assessments |
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Validation of data |
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Veterinary Master Files |
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