Authoring and reviewing regulatory documentation for IBs, INDs, ANDAs, NDAs, DMFs, BLAs, CPPs, IDEs, De Novas, 510(k)s, and PMAs
- Advising on regulatory interactions with FDA and other international agencies, including expedited programs such as INTERACT, RMAT, Breakthrough, and Fast Track
- Consulting on pharmacology, toxicology pharmacokinetics, and ADME
- Support lifecycle management of regulatory submissions of amendments, supplements, annual reports, DSURs, and PADERs
- Prepare regulatory meeting requests and requisite briefing packages
- Provide strategy and support with drug listings and facility registration
- Provide strategy and support with EPA medical device registration
- Global eCTD publishing
- Former FDA Consultants
- Inspectional readiness programs
- ISO 13485:2016 certification readiness program
- GLP, GCP, GTP, and GMP Expertise
- Import Export regulatory logistic services