Consultation CMC

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We stand for international, individual, innovative and intelligent solutions to support your development,registration and marketing authorisation (MA) projects. To do so we accompany our clients through allregulatory activities, whether traditional registration, national and international procedures includingvariations and renewals, dossier updates or the extension of pharmaceutical product lines.The regulatory services for human and veterinary medicinal products provided by i.DRAS GmbH coverthe whole product life cycle. These activities range from preclinical development stages to the first submissionof the MA dossier and post-marketing activities. Our service promotes all types of regulatory activities,from investigational medicinal products to new, generic or bibliographical applications to achieve MA fornew and established drug substances and the corresponding drug products.This includes medicinal products containing herbal as well as chemical entities and biotechnological products.Among post-marketing activities we provide our expertise for dossier updates, variations, renewals, line extensionsand mutual recognition procedures.Medical devices and drug-device combination products differ in their regulatory requirements comparedto medicinal products. We help manufacturers to obtain certification for these products as a prerequisite toEuropean market access. Clinical evaluation, assessment of biological safety and the collation of technicaldocumentation are our particular strengths. Whenever it is necessary to establish whether a product hasto be regulated as a medicinal product or medical device, we provide our long-term expertise.As expert partners we oversee the certification of substance-based medical devices and drug-device combinationproducts and all types of due diligence pertaining to dossiers and documents in this context.
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