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The FDA submission process can seem like a maze whether your company is multinational with extensive regulatory experience or newly emerging in the marketplace. We can help you with the following services:
Application and Submission Services
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Assistance with Regulatory Strategies and Assessment of Drug Development Program
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Preparation of Submissions - DMF, IND, NDA, ANDA, BLA, CTD
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Special Meeting Scheduling and Briefing Package Preparation
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Application Amendment and Supplement Preparation and Submission
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FDA/EU Liaison
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Non-Clinical
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Non-Clinical Program Assessment, Development and Strategies by Drug Class
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Protocol Development/Study Monitoring/GLP Audit
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Report and Summary Preparation
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Clinical
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Assistance with FDA's GCP Requirements
for Sponsors, Monitors, and Clinical Investigators |
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Good Clinical Practice (GCP) Audits/Monitoring, Data Integrity Audits |
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Statistical Reports |
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Good Clinical Practice and Human Subject Protection Compliance |
CMC Section Development
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Drug Substance Development Report and Preparation
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Drug Product Development Report and Preparation
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Post Marketing Reports to FDA (NDA Field Alerts)
Product Labeling & Listing
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Drug Product Labeling - Rx and OTC |
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Drug Product Listing
— Preparation and Submission of FDA Form 2657 |
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Client Registration
— Preparation and Submission of FDA Form 2656 |
US FDA Agent Services for Foreign Clients
Please contact
us for additional information or to get help now!
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