SERVICES - Regulatory support

SERVICES - Regulatory support

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VitalDose(R) Ethylene-vinyl acetate copolymers (EVA) have been approved for use in numerous pharmaceutical and medical device applications around the world. GMP Manufacturing is performed in accordance to IPEC guidelines for Pharmaceutical Excipients*. Drug Master Files and technical dossiers are provided to support are available for customers' regulatory approval. Celanese provides various certifications to address technical requirements and regulatory compliance, including but not limited to USP Class VI and ISO10993 biocompatibility, European Pharmacopeia, European and FDA Food Contact, REACH, etc. * NSF/IPEC/ANSI 363 - 2014 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients
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CelaneseCelanese is a global technology and specialty materials company that engineers and manufactures a variety of products essential to everyday living. Celanese has supported key applications and the demanding requirements of the medical market for over 40 years and has developed one of the broadest ranges of special thermoplastics in the world. We are expanding design possibilities as our customers find new ways to improve patient care with cutting-edge medical and pharmaceutical material solutions. Working at the intersection...

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