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Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Line extension

Post-approval development for a medium sized biotech

BioVentures Consulting Limited was approached to work with the client’s regulatory group on the development strategy for line extension of a previously approved product. The assignment consisted of working with the client’s formulation development team to develop a new formulation offering improved safety and delivery characteristics for submission to the US FDA. The brief also involved co-ordination of inputs for the briefing document for a Type C meeting, as well as key questions for a series of EU Scientific Advice meetings, and assembly of the CTA. The end point was the development of a new formulation which the client had selected to take forward in a development strategy which had been agreed with key regulatory agencies.

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