About company

The pharmaceutical industry is becoming increasingly complex – including the use of biotechnology to develop and manufacture new types of therapeutic agents, incorporating medication adherence technologies, and combining traditional pharmaceuticals, medical devices, and biological substances in a single product. Correspondingly, regulatory bodies have issued or updated their rules and guidance. In the US, this includes 21 CFR Part 210, 21 CFR Part 4, and 21 CFR Part 610, while ISO has issued ISO 15378 for pharmaceuticals distributed in the European market.

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