Regulatory Affairs Solutions

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This report analyzes 510(k) clearances of medical devices by the Food & Drug Administration in 2009, according to medical discipline, time to decision and a variety of other categories.

FDA Consultants will immediately supplement your organization to provide various regulatory solutions, including various product dossiers and submissions for review and approval by the authorities such as FDA and International Regulatory Authorities.

Regulatory Submissions: Our Consultants provide our clients guidance through the entire regulatory submission process.

Our consultants have both industry experience in preparing submissions and have an excellent track record for interfacing with the appropriate regulatory authorities and helping firms achieve their regulatory objectives.

We provide the following Regulatory Services:

Medical Devices and IVD Submissions

» 513g Request for Classification

» Pre-IDE

» Market Notification (510k)

» Investigational Device Exemption (IDE)

» Pre Market Approval (PMA)

Pharmaceuticals and Biologics Submissions

» Investigational New Drug (IND)

» New Drug Application (NDA)

» Biological Application License (BLA)

Combination Products Submissions

» Request for Designation (RFD)

» Drug/Device with Drug PMOA- NDA with PMA

» Device/Drug with Device PMOA- PMA with NDA

We look forward to speaking with you about your specific project needs. Please use the Contact Us form so we can assign the right expertise for further discussion or for an immediate response call 800 782 0580.