Regulatory Affairs Services
Our regulatory affairs expertise ensures that regulatory strategies and alternatives are considered at every step of the process, we ensure top-quality documentation to help you gain product registration as expeditiously as possible, and avoid unnecessary delays and duplication. At FABEL Consulting, we leverage a horizontal strategy to achieve an effective targeted dossier compilation with minimum time and maximum efficiency, without compromising your eminence.
FABEL can assist you with:
Regulatory affairs representation and liaison servicesReviewing technical dossier and development planGeneral consultation on FDA, EMEA and ICH requirementsInterpretation on U.S. 21 CFR regulationsPreparing submissions, from pre-meeting packages through post-marketing changesAuthoring, reviewing and compilation non-clinical sections of your submissions:o Clinical trial applications and notifications (IND, CTA, CTX, NC)o Marketing applications (NDA, ANDA, MAA, CTD, IMPD, BLA)o Amendments, supplements, annual reports, quality overall summarieso Variation packagesCoordinating your field corrective actionsCosmetic labellingAuthoring MSDSManaging regulatory content for Cosmetics and Chemicals registration