RAPHAMED LLC

RAPHAMED LLC provides Regulatory Affairs Consulting for the Pharmaceutical and Medical Device industries. Led by Soby M. Fennell, an accomplished strategic Regulatory Affairs professional with over 20 years of pharmaceutical industry experience, the RAPHAMED team can provide guidance and support for an entire spectrum of needs, from early stage development strategies to downstream launch execution and commercialization efforts, for a wide array of dosage forms, molecules, and therapeutic areas. The team has extensive experience with: • Due Diligence • Regulatory Affairs Training and Workshops • IND/NDA/ANDA Meetings and Meeting Packages • Author, review, and publish Modules 1 - 5 in eCTD format • IND/NDA/ANDA/505(b)(2) Applications and Amendments • Labeling • OPDP Ad Promo Review and Submission • Citizen Petitions • Orphan Drug Designation Requests • Initial Pediatric Study Plans (iPSP) • Controlled Correspondence • Post-Approval Supplements • Lifecycle Maintenance Submissions • Drug Listing