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
Company Details
- Employees
- 1
- Founded
- -
- Address
- New Hope, Pa 18938, Us
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Keywords
- São Paulo.
- HQ
- New Hope, PA
Raphamed Llc Questions
Raphamed Llc's LinkedIn profile is https://www.linkedin.com/company/raphamed-llc
Raphamed Llc has
1 employees.
View email and phone details for 1
employees at Raphamed Llc.
Raphamed Llc's industry is
Pharmaceutical Manufacturing
Raphamed Llc's top competitors are
Nick Saúde,
Menrv.ai,
Day One Biopharmaceuticals,
Aucta Pharmaceuticals Inc.,
Rapha Medtech,
Bertha Design.
Raphamed Llc's categories are Pharmaceutical Manufacturing
Raphamed Llc's founding year is 2019
