RPI Regulatory Experts: Paving the Way for Chinese Pharma Globalization by Tackling the 'Impossible'

As China’s pharmaceutical industry increasingly aligns with the global system, Chinese pharmaceutical companies that have just begun to “go global” are not only seizing opportunities but also facing numerous challenges in the international market. In an environment of constantly evolving regulatory requirements, sponsors may consider partnering with experienced CROs. Leveraging their extensive expertise, these CROs can help sponsors develop optimized R&D and regulatory strategies tailored to client and project specifics under the current regulatory landscape, thereby mitigating risks and accelerating the R&D process.

The RPI division, affiliated with Pumir Pharma, was established in 1995 to meet the growing needs of local biotechnology and pharmaceutical companies by providing global support for their product development and registration. The RPI expert team offers comprehensive strategic and tactical product development expertise throughout the entire development lifecycle of drugs, biologics, medical devices, drug-device combinations, or diagnostic tools, helping guide clients in achieving their drug development objectives.

RPI’s regulatory consultants have accumulated up to 25 years of extensive experience in liaising with regulatory agencies such as the FDA and preparing complex registration submissions that require specialized and strategic regulatory expertise. Their proven track record and practical approach ensure that RPI is a trusted partner. Through highly customized solutions, RPI has helped hundreds of clients achieve their regulatory registration milestones.

Leveraging comprehensive expertise in product development and regulatory registration, RPI’s expert team helps clients formulate precise R&D strategies through streamlined and customized approaches, enabling them to avoid pitfalls and rapidly achieve their drug development goals.

RPI provides comprehensive strategic and regulatory expertise across all stages of research and development, helping clients mitigate risks. RPI’s regulatory consultants are highly adept at liaising with global authoritative bodies such as the FDA and EMA, thereby maximizing the success rate of regulatory submissions.

RPI’s medical writers are technically on par with subject-matter experts and possess extensive experience in drafting and submitting medical and regulatory documents, ensuring the timely submission of high-quality deliverables.

When Other CROs Say “No,” RPI Says “Yes”

In a real-world case, a sponsor approached several CROs for assistance with a project goal deemed “nearly impossible” to achieve. While multiple CROs declined the request, RPI accepted the challenge. Surprisingly, RPI not only helped the client meet the project objectives on time, but the results also far exceeded the client’s expectations.

In this case, the sponsor was completing Phase III studies of an antibacterial and anti-infective drug and needed to submit a New Drug Application (NDA) by June 30, 2015. While new drug registration typically takes one to one and a half years, the sponsor in this project had only six months! The magnitude of the task is evident from this constraint alone. Within such a compressed timeframe, the R&D process itself posed numerous challenges, including the need to manage complex research data spanning more than 12 years. To make matters worse, the sponsor had not yet requested a pre-NDA meeting with the FDA, a step that is usually taken one year prior to NDA submission.

In light of the project’s unique circumstances, RPI’s expert team leveraged its extensive regulatory experience to secure an FDA meeting within a short timeframe—months ahead of the standard schedule. Working around the clock, the team analyzed heterogeneous data spanning over 12 years and addressed significant data gaps. To meet the “nearly impossible” submission deadline, RPI adopted a rolling review approach to accelerate the process. Ultimately, within just six months, the FDA accepted the sponsor’s New Drug Application (NDA). This marked a record-breaking speed for PulmX Pharmaceuticals in new drug registration.

As a global clinical research CRO, Premier Medicine focuses on providing comprehensive services for the global registration and clinical research of biopharmaceuticals and medical devices, with business operations spanning the globe. Premier Medicine courageously takes on challenges that other CROs shy away from, dedicating itself to serving clients across various sectors by leveraging professional talent and regulatory expertise to accomplish one “impossible” mission after another.