services
combination product and device development from pre-design controls through design transfer and post-market, bolstered by over a decade of experience in product development and project management
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ISO 13485
ISO 14971
EU MDR / Article 117
US FDA CFR Parts 3 & 4
pharmaceutical cGMPs & device cGMPs
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regulatory strategy
expertise in drug- and biologic- device combination product regulation
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single entity, co-packaged, &
cross-labeled/cross-referenced/combined use
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pre clinical through post-market
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US, Canada, EU, Australia, New Zealand, South Korea, Japan
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components, devices, final combination products
health authority interaction
planning, strategy, and execution of health authority meetings and/or correspondence
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project management ensuring timely and thorough processes and work products
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authoring of health authority interaction packages
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health authority inspection preparation and support
dossier authoring
IND, IMPD, CTA/CTN, NDA, BLA, ITA device and combination product content for respective associated markets
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region specific labeling (IFU, PI, SmPC)
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notified body opinion (NBOp) technical documentation
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drug master files (DMFs)
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device master files (MAFs)​​