Syner-G BioPharma Group has the capability and experience to format, compile, publish, and submit all of your required regulatory documents to global regulatory authorities. We make hundreds of electronic submissions every year to the U.S. FDA via the Electronic Submissions Gateway (ESG), as well as to the European Medicines Agency (EMA) and National Competent Authorities around the world.
Our Regulatory Submissions staff has the extensive training and experience needed to manage and execute each step of the electronic submissions process. Our processes and procedures ensure that every electronic submission we make on behalf of our clients is of the highest quality and adheres to all local regulatory requirements, including 21 CFR Part 11 compliance in the U.S.
Using validated and 21 CFR Part 11 compliant publishing software that is widely recognized within the industry and across Regulatory Agencies (including the FDA), we can publish and electronically submit your IND or NDA/BLA and subsequently manage the lifecycle for either of these types of applications. Our publishers have worked on hundreds of INDs in the U.S., either publishing the initial application or managing the lifecycle submissions, as well as numerous NDAs and BLAs that were successfully filed with the FDA. Outside of the U.S., we have successfully filed numerous marketing applications to regulatory agencies such as the EMA, Health Canada, and Swiss Medic.
Our Regulatory Submissions team also provides:
- Formatting and pre-publication services to ensure your documents are submission-ready with the necessary bookmarks and hyperlinks for inclusion in an eCTD submission
- Report-level publishing of documents (e.g., clinical study reports) for inclusion in regulatory submissions
- Submission of Drug Master Files (DMFs)
- CTA submission support outside the U.S.
Whether you are a small company requiring management of all of your electronic regulatory submission needs or a large company requiring assistance with a single submission, Syner-G will tailor our offerings to your specific needs. Once you make the decision to partner with us, our Regulatory Submissions staff will become a valued member of your team.