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Your Best Resource |
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When it comes to meeting FDA regulatory and compliance requirements experience counts, and we deliver |
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Regulatory Affairs |
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We offer a full range of regulatory affairs service from strategic planning and meeting with FDA to electronic submissions. ● Strategies planning and guidance throughout the regulatory submission process ● CMC section development & preparations ◦ Writing CMC (Module 2 and 3 sections) for drug products and drug substances ◦ Writing reports for completed studies ● Preparation of dossiers and submissions for DMF, IND, NDA, ANDA and BLA ● Preparation of required amendments ● Preparation of required Post-approval change supplements (PAS) ● Special meeting request and scheduling ● Meeting briefing package preparation & submission ● Critical review of prepared submissions ● Drug product labeling preparation ● Drug product registration and listing ● Facility registration ● Gateway set up for clients ● Electronic submissions of dossiers ● Helping clients to resolve their electronic submissions issues when they have in house publishing tools |
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Full Regulatory Services:
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Quest International Consulting 26180 Enteprise Way Suite 300 Lake Forest, CA 92630 USA Phone: 949-297-4445 Fax: 949-215-3434
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● Strategic planning ● Preparation, review, ● and submission of ● CTD and eCTD submissions ● Product registration ● SPL preparation ● Facility registration |
