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:

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SOP Development

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Quality Agreements

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Vendor Audits

N

Mock FDA Inspections

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Warning Letter & 483 Responses

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Finished Product Market Release (for virtual manufacturers)

N

CMO qualification and oversight

N

Drug product technical analysis

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Dossier review

N

Due Diligence Assessments

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Technical Transfer Assessment

N

Pharmacovigilance Services

FDA US Agent Services

The responsibilities of the U.S. Agent are limited and include:

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Providing U.S. regulatory representation for foreign establishments. Pharmobedient can represent and guide your company in U.S. market.

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Assisting FDA in communications with the foreign establishment

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Responding to questions concerning the foreign establishment’s drug or device products that are imported or offered for import into the United States

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Assisting FDA in scheduling inspections of the foreign establishment

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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

2 + 8 =

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