FDA Regulatory Compliance
FDA Regulatory compliance is critical to the development and successful commercialization of pharmaceutical products. A strong regulatory strategy and robust technical knowledge is the backbone of the drug development process. You can rely on Pharmobedient for expert guidance throughout the Molecule to Market process, from beginning to a successful end.
Services
FDA Regulatory compliance services include:
SOP Development
Quality Agreements
Vendor Audits
Mock FDA Inspections
Warning Letter & 483 Responses
Finished Product Market Release (for virtual manufacturers)
CMO qualification and oversight
Drug product technical analysis
Dossier review
Due Diligence Assessments
Technical Transfer Assessment
Pharmacovigilance Services
FDA US Agent Services
The responsibilities of the U.S. Agent are limited and include:
Providing U.S. regulatory representation for foreign establishments. Pharmobedient can represent and guide your company in U.S. market.
Assisting FDA in communications with the foreign establishment
Responding to questions concerning the foreign establishment’s drug or device products that are imported or offered for import into the United States
Assisting FDA in scheduling inspections of the foreign establishment
If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. Agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
Contact
COMPANY
Strategy for complex issues in drug development and life-cycle management.
CONTACT
642 NE 3rd Avenue
Fort Lauderdale FL 33304
TEL. #
(954) 348-9455