Trust in the Leading CRO in China

PHDS expertise and professionals are widely recognized for excellence by industry peers and customers. With a reputation as a preeminent contract research organization (CRO) in China, PHDS brings a deep understanding of regulatory requirements to every project, keeping your research on time and on budget and provide full clinical research solutions to biotech, pharmaceutical, medical device and health industries worldwide. In the relentless pursuit of excellence, we are passionate, deliberate and driven by our purpose – to improve health.

 

Our Regulatory Affairs team brings more than 20 years’ experience navigating the complex regulatory environment. We leverage our experience to allow our clients to focus more time on bringing their lifesaving products to market. With the regulatory capability, knowledge, and experience to efficiently manage products throughout their complete regulatory life cycle, PHDS regulatory affairs team provides China-specific and local regulatory expertise and acts as client representatives for registrations and submissions, including direct communications with regulatory authorities. PHDS regulatory affairs department is comparably structured to health, pharma and biotech regulatory organizations, which means we build our project teams to meet your needs while not duplicating efforts.

 

Service Scopes

We anticipate problems, find solutions and deliver results; we bend the cost and time curve of product development and optimize value through innovation and continuous improvement.

 

I. Clinical Development

● Clinical Trial Management (Local and Multi-Regional Clinical Trial)

● Clinical Data Management

● Programming & Statistical Analysis

● Project Management

 

PHDS helps you navigate the evolving Chinese regulatory landscape and strategically shorten approval timelines and efficiently get your product into China and beyond. We offer a full spectrum of supports to you, including regulatory submission and management, regulatory consulting and intelligence, medical writing and quality review – everything is available for you from our flexible and customized service model, comprising cross-functional team members that provide full regulatory, scientific and medical writing support across the entire product life cycle. We leverage the regulatory capability, knowledge, and experience to efficiently manage products throughout the complete regulatory life cycle. Our team provides the regulatory expertise and acts as your representatives for submissions, including direct communications with local industry-leading experts and regulatory authorities. We develop project plans on the ground of in-depth knowledge and experience in of Chinese regulatory processes and timelines that anticipate the requirements for product approval and mitigate risks or challenges that may arise.

 

II. Regulatory Affairs

● Investigational New Drug (IND) application

● New Drug Application (NDA)

● Drug application for OTC Drugs

● Medical device registration

● Active Pharmaceutical Ingredient (API) / drug substance registration

● Pharmaceutical excipient registration

● Pharmaceutical Packaging Material registration

● Functional Food registration

● Novel Food Ingredients registration

● Food Additive registration

● Cosmetics registration

● Disinfectant registration

● Drinking Water Device Hygiene Certificate Application

● Drug Registration Renewal (Re-registration) and Supplementary Application

● Regulatory Chemistry, Manufacturing and Controls (CMC)

● Regulatory labeling

 

Our flexible and customized service team comprises cross-functional team members that provide full regulatory, scientific and medical writing support across the entire product life cycle. Our combined industry and CRO experience allows us to provide expert regulatory project management and consultancy services to meet your complex and evolving needs.

 

III. Training

● CRA Training

● Clinical Data Management Training

● Biostatistics Training

● Medical Writing Training

 

 IV. Technical Services

● Policy/Regulation Consultation

● Market Access Service

● Process Development and Modification, Technical Parameters Investigation

● Specification Development and Modification

 

Request a proposal now