Services: Regulatory Submissions
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Cato Research has the experience and technology for efficient and quality compilation, filing, and maintenance of regulatory submissions for any product type, development stage, or region.
Examples of Submission Experience
- Abbreviated New Drug Applications (ANDAs)
- Biologic License Applications (BLAs), Amendments, and Supplements
- Clinical Trial Applications (CTAs)
- Clinical Trial Exemptions (CTXs)
- Division of Drug Marketing, Advertising, and Communications (DDMAC)
- Drug Master File (DMF) Annual Reports and Amendments
- Fast Track Applications
- Investigational Device Exemptions (IDE)
- Investigational New Drug (IND) Applications and IND Amendments
- Marketing Authorization Applications (MAAs)
- Meeting Information Packages
- New Drug Applications (NDAs), Amendments, and Supplements
- New Drug Submissions (NDSs)
- Orphan Drug Applications (ODAs)
- Premarket Approvals (PMAs)
- Pre Market Notifications (510k)
Our trained staff has extensive experience preparing and submitting all types of regulatory dossiers. We strive to partner with you early in development in order to ensure that regulatory actions can be firmly supported by the development program. In addition, we have broad experience in interacting with regulatory agencies to obtain general agreement on the content and format of applications. Our regulatory personnel are specifically trained in the following areas that serve to expedite product development and ensure compliance in marketing applications:
- Coordination of documentation for products seeking international approval (e.g., US, EU, Canada)
- Utilization of the Core Data Sheet throughout all stages of product development
- Current regulations/guidances and recent initiatives on Summary of Product Characteristics and US Package Inserts
- Current electronic labeling initiatives (e.g., SPL, PIM)
- Current publishing software and xml coding
- Quality control review to ensure complete compliance with FDA and ICH standards