International Regulatory Publishing

Learn What Your Submission Needs for Acceptance

Does your pharmaceutical or biotech company need assistance with your global regulatory publishing? This process can be lengthy and frustrating if you’re trying to navigate it on your own.

However, with the help of SopReg Consulting (SRC) and our global regulatory publishing services, you’ll be able to quickly and efficiently go through the regulatory publishing process. SRC offers assistance and solutions for global regulatory publications such as:

• Investigational and Marketing application submissions
• Investigational New Drug (IND) submissions
• New Drug Application (NDA) submissions
• Abbreviated New Drug Application (ANDA) submissions
• Biologics License Application (BLA) submissions
• Drug Master File (DMF) submissions
• Marketing Authorization Application (MAA) submissions
• Non-eCTD electronic Submissions (NeeS)
• Other Submissions
• Briefing documents
• Protocols/amendments (Phase 1-4, registries)
• Information Amendments for CMC/Clinical
• Investigator Brochure (IB)
• Clinical Study Report (CSRs)
• DSURs
• Safety Submission
• ODD
• Annual Reports
• Case Report Form (CRFs)
• Rest of the world submission (ROW)
• Clinical Trial Application (CTA)
• Genetically Modified Organisms Application (GMO)
• Lifecycle maintenance submissions
• eCTD Granularity
• eCTD Metadata
• Paper to electronic common technical document (eCTD) conversions

We have never had a submission rejected, and we strive to attain the fastest review-processing rate possible. Call SopReg Consulting (SRC) today for a free consultation on global regulatory services.