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Home / Pharma Solutions / Fine chemicals / Support for regulatory affairs

Support for regulatory affairs

Many countries require notification of new chemicals. Novasep offers full assistance in developing safety data up to the preparation and submission of a notification. We provide registration support for various countries and regulatory bodies including the US EPA, European ECHA (REACH) and Japan CSCL.

Quality Assurance

Novasep’s quality management system is based on the international quality standard ISO9001. Every contract manufacturing site has a quality system in place ensuring that your products are of the quality required for their intended use and that quality management systems are maintained.

Optionally and upon customer request, Novasep also offers the possibility to carry out production in full compliance with current Good Manufacturing Practice (cGMP) or ICH guidelines. We also have accreditation to handle food grade material or GMOs within our facilities.

 

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