To the uninitiated, the world of regulatory affairs can feel like the last thing anybody wants to think about.
Imagine, though, someone being able to tap you on the shoulder and save you months of delays simply by advising a more efficient strategy for getting your product approved?
Suddenly, the pencil-pushers are bringing you months closer to profitability.
You tell us what you want to accomplish, and we'll advise you how to best handle the filing.
Sovereign is committed to developing and manufacturing high-quality products. We emphasize the development and filing of the whole gamut. We offer expert services in all aspects of the development process and filed products. We perform all stability studies under ICH guidelines, assemble the CMC section, and file the applications in eCTD format with the FDA on our customer’s behalf (or can provide a package to you that is submission-ready). Our regulatory staff also has the expertise to monitor biostudies, if required, and can handle your labeling needs.
- Key Activities for ANDA or 505(b)2 NDA
- Prepare Development Plan
- Evaluate API and Excipients
- Review and Evaluate Stability of API
- Verify Analytical Methods
- Conduct Pre-formulation and Formulation Activities
- Request and Attend Pre-IND Meeting with FDA if required
- Develop and Validate Analytical Test Methods
- Perform Cleaning Verification Studies
- Manufacture Proof of Concept Batches
- Manufacture Exhibit Batches
- Conduct ICH Stability Studies
- Submit IND
- Support BA/BE Biostudies
- Assemble application
- Submit application in eCTD format
Regulatory Affairs Services
- Preparation and Electronic Submission of IND Applications and Amendments (e.g., Protocols, Investigator Brochures, CMC)
- Preparation and Electronic Submission of ANDA [505(j)] and NDA [505(b)(1) and 505(b)(2)] Applications
- Preparation and Coordination of Responses to FDA Requests for Information
- Preparation and Submission of Annual Reports
- Post Market Surveillance and Post Approval Changes
- ANDA and NDA Site Transfers
Clinical Affairs Services
- Pre-IND Meeting Requests, Preparation and Electronic Submission of Briefing Packages
- Development of Clinical Plans and Strategies
- Participate in FDA Meetings
- Clinical Trial Monitoring and Data Management
- Auditing for Compliance with FDA Regulations, SOPs, and Protocols
- Liaison with Sponsors, Vendors, and Project Teams