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ASC Consultants can prepare various kinds of regulatory
submissions for our clients in order to achieve their goals.
submissions for our clients in order to achieve their goals.
- FDA regulatory submission preparation/review for
- Pre Market notification - 510(K)
- Investigational New Drug – (IND)
- New Drug Application – (NDA)
- Pre Market Approval - (PMA)
- Investigational Device Exemption - (IDE)
- Device Master File (DMF)
- Biologic License Applications – (BLAs)
- Provide liaison activities with federal agencies
- Clarification of FDA regulations and expectations
- Advice on various strategies with FDA (e.g:
Regulatory/Development strategy) - Preparation for FDA meetings and Advisory meetings
- Non-US Regulatory Submission - Canada, Japan and
EU markets - Due diligence review of regulatory files
- Develop product labeling and advertising copy
- Initiate establishment registrations
Our Mission
© Advanced Solutions Consultants (ASC, LLC). All rights reserved.
| SERVICES: REGULATORY AFFAIRS |
To provide complete solutions to Quality, Regulatory, New Product Development and Compliance challenges. We are dedicated in supporting our clients in the Device, Diagnostics, Pharmaceutical, Biologics and Combination Product industries in maintaining high standards of Quality in their practices and in their products. We encourage you to contact us for more information. |
| Contact us: Admin@ASC-FL.com 954-344-8284 |
