TRIVERITAS
REGULATORY AFFAIRS
REGULATORY AFFAIRS
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REGULATORY AFFAIRS | |||
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| Triveritas has international experience in regulatory affairs and product registration. We can assist companies from the earliest stages of technology and product selection by providing expert guidance on regulatory strategy and requirements, at international, pan-European and national levels. As development proceeds, ongoing advice on the pre-marketing requirements and data evaluation can be provided, including the preparation and submission of regulatory applications for both animal trials and marketing approval. | ||||
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Liaison and negotiation with regulatory authorities. | ||
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Obtaining regulatory approval for conduct of trials. |
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Preparation of expert reports. | ||
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Obtaining MRLs. | ||
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Registration of new and established active substances, including novel formulations and delivery systems. | ||
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Strategic regulatory consultancy, expert guidance on requirements, evaluation of data and advice on cost-effective development programmes. | ||
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Post-marketing support and compliance – routine regulatory maintenance, variations, renewals, review of promotional materials, labels and leaflets. | ||
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