​​​​​​Regulatory Affairs

ShujuMetrics is recognized as a professional clinical research organization (CRO).  We provide a wide range of registration services including drug registration, and medical device registration.  With flexible service programs, we can provide complete or partial services during the registration procedure, and accelerate the registration process to expedite your product to market. 

Our Regulatory Affairs Team

We have a professional team experienced in regulatory affairs.  All regulatory staff have graduated from elite medical/pharmacology universities with a comprehensive understanding of technology and related laws.

Regulatory Consulting

We evaluate and access opportunities for pharmaceutical clients to introduce new compounds or products to the US market. Design global regulatory strategies and clinical pathways to ensure feasibility and creativity in clinical development and registration procedures. We provide ongoing surveillance of all our projects and ensure local and regional guidance, regulations, and laws are followed. We:

  • Provide consultations to clients and design competitive regulatory landscapes to support the product launch
  • Prepare the submission package including documentation and  reports publication, electronic Common Technical Document (eCTD)
  • Submission planning, eCTD submission formats building, documentation optimization, and paper submission publication
  • Review submission package and provide in-house server for secure data transfer and storage
  • Provide regulatory support for particular therapeutic area through our regulatory partners and consultants
  • Maintain product dossier and update annual reports, DSUR, PSUR per agency requested


With flexible service offerings, we can provide whole or partial services during the registration process:

  • Registration feasibility analysis
  • Registration information writing, translation and collation
  • Registration information pre-evaluation
  • Registration application submission
  • Inspection during product registration
  • Query solutions during registration
  • Conduction of the clinical trial
  • Submission of clinical results and other amended or supplementary data
  • Development of product marketing certificates

(CFDA) Drug Registration Services

We provide registration services for both imported drugs and domestic drugs,including chemical drugs, traditional Chinese medicinal, biological products and global multi-center clinical trial approval. We can help:

  • Analyze the registration feasibility
  • Collate the application information
  • Apply for the registration

Medical Device Registration

Medical devices refer to any instrument, apparatus, appliance, material, or other product whether used alone or in combination on human body, including the software necessary for its proper application. It does not achieve its principal purpose in or on the human body by means of pharmacology, immunology or metabolism, but may be assisted in its function by such means.

 Medical Device Registration Services

  • Development of product registration standards and technical files
  • Contact related testing organization and submit the tested device,if required
  • Follow up whole testing procedures
  • Develop clinical protocols and coordinate clinical trials, if required
  • Registration application submission
  • Answer any questions during the registration
  • Approval for registration certificates