services
available for fractional, contract, project-based, and advisory engagements
leadership of multiple, successful FDA Meetings (OCP, CDER, CDRH), including novel regulatory strategies
authoring of drug-device/device only sections of approved INDs/IMPDs/CTAs for various clinical phase studies
&
drug-device/device only sections of approved NDAs/BLAs/supplements
product development & design controls
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
ISO 13485
ISO 14971
EU MDR / Article 117
US FDA CFR Parts 3 & 4
pharmaceutical cGMPs & device cGMPs
regulatory strategy
expertise in drug- and biologic- device combination product regulation
single entity, co-packaged, &
cross-labeled/cross-referenced/combined use
pre clinical through post-market
US, Canada, EU, APAC, LATAM, global
components, devices, final combination products
health authority interaction
planning, strategy, and execution of health authority meetings and/or correspondence
project management ensuring timely and thorough processes and work products
authoring of health authority interaction packages
health authority inspection preparation and support
dossier authoring
IND, IMPD, CTA/CTN, NDA, BLA, ITA device and combination product content for respective associated markets
region specific labeling (IFU, PI, SmPC)
notified body opinion (NBOp) technical documentation
drug master files (DMFs)
device master files (MAFs)