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Eurofins BioPharma Product Testing

phone +32 2 766 16 20
email pharma@eurofins.com
web http://www.eurofins.com/Biopharma
email Chaussée de Malines, 455 B-1950 Kraainem

Bio/Pharmaceutical Methods: Do your Analytical Methods Hold Up to Regulatory Scrutiny?

As FDA guidelines evolve and drug products on the market begin to age, bio/pharmaceutical manufacturers face scrutiny of the original methods used to support these products. Therefore, manufacturers must re-evaluate these methods to ensure they comply with current FDA expectations. Some manufacturers are even facing consent decrees imposed by the agency requiring them to bring methods up to current standards within a specified timeframe. This exercise requires significant amounts of time and resources, which many manufacturers do not have since they are focused on getting their next products to market. For that reason, some clients have been turning to Eurofins Lancaster Laboratories for support.
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