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Enabling Successful US Submissions for Chinese Biotech Companies

Domestic selling constraints on their products are prompting Chinese pharmaceutical companies to seek success abroad. For Chinese companies looking to submit applications to the United States (US) this year, thinking about how and where to start in the publishing and submissions process is daunting. For Chinese BioPharma, the goal is to file to both the Chinese National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA). However, in many cases, these companies lack US filing experience, and the fear of rejection can create challenges to meeting this goal.

To assure success, it’s important to partner with a regulatory operations (“reg ops”) team that has experience working with Asia Pacific (APAC) companies. Here are three characteristics that APAC companies planning to submit to the US should look for in a regulatory operations team.

What makes a regulatory operations team best suited to support APAC companies with US submissions?

Deep industry knowledge

Approval in the US can be viewed as recognition of a drug’s efficacy and safety results, a drugmaker’s independent research and development, and global execution capability. For many APAC companies, it may be the very first time they’ve considered submitting to the US. Because of this, companies’ teams lack knowledge of US regulations and the overall submission process. These companies are looking for a regulatory operations team to provide all the industry and regulatory insight needed while offering iterative consultation and quality assurance during the submission process. This reg ops team should be able to pose the right questions to the regulatory agency to ensure nothing is missed or overlooked during the submission. Certara Synchrogenix’s reg ops and eCTD publishing specialists have the industry experience and FDA knowledge to help guide APAC companies every step of the way. In fact, we’ve completed more than 5000 submissions since 2018 with 5 marketing application approvals in 2021.

Ability to manage multiple products

Gaining FDA approval opens the door to overseas expansion and endorses a company’s research and development capability. For companies with multiple products, the regulatory operations team should be able to assist with submissions for all their products. Certara’s proprietary GlobalSubmit technology facilitates technical review and publishing of compliant submissions for various health authorities, including the FDA, Health Canada, European Medicines Agency (EMA), and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA). Global Submit is eCTD software that enables efficient publishing, validation, and review of regulatory submissions while ensuring timely review of all of submission components.

Longstanding partnership

The road to approval may be long, so it’s important that your reg ops team is there for the ride. A partner that can ensure consistent teams and point of contact and is fully informed on a company’s products and all submission requirements may make the difference between a successful and unsuccessful submission.  

Certara Synchrogenix’s reg ops team assigns multiple contacts and follow-the-sun resources to stand by your project from start to finish, no matter how long the journey. This team can help guide and facilitate discussions with regulatory agencies and alleviate any fears you may have concerning your FDA submissions. Partnering with Certara Synchrogenix’s reg ops team of specialists provides you with the expertise and software solutions you need to help review and approve submissions efficiently.

Success with APAC companies

Certara Synchrogenix has worked with a variety of Chinese companies, some for several years, in support of their US submissions. One such company headquartered in China has partnered with us since 2019 on numerous submissions. Our reg ops team has supported six applications across more than three products. This partnership was further nurtured by assigning a dedicated team to each project. Currently, we are also working to support the company’s upcoming marketing applications.

Another company, headquartered in China, came to Certara to request support for its very first application to the FDA. They required a long-term partner to guide their team every step along the way. Our well-versed and knowledgeable regulatory operations team of specialists assured submission success through devoted submission management. Read more about our successful partnership with one of these companies in this case study.

About the author

Gabriella Mangino
By: Gabriella Mangino

Gabriella Mangino has years of patient narrative production and project lead experience in the pharmaceutical industry. As a Product Manager at Synchrogenix, Ms. Mangino works with the commercial and services groups to help develop and improve the software that supports our technology-enabled authoring capabilities.

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