Delivering What Matters to Biopharma
Our dedicated device team includes industry veterans from Philips and Medtronic, as well as external experts from China's CDE, providing deep insight into both global innovation and local regulatory pathways.
We support clinical development for:
Diagnostic and therapeutic devices across the cardiovascular, ophthalmic, respiratory, and surgical fields
Class II and III device registration trials under NMPA and FDA requirements
Performance evaluation, usability studies, and post-market safety surveillance
Vaccines:
GCP ClinPlus has successfully led large-scale vaccine trials, including global Phase III COVID-19 studies, offering:
Rapid patient enrollment across China and international sites
Cold-chain logistics coordination and site training
Compliance with WHO prequalification and ICH-GCP standards
Herbal Medicines (TCM):
We bring modern clinical trial design to traditional Chinese medicine (TCM) development. Our services include:
IND and NDA strategy for herbal compounds
Syndrome differentiation, integration, and efficacy endpoint validation
Trial documentation aligned with both modern pharmacology and TCM evaluation standards
By combining regulatory foresight, operational agility, and domain-specific expertise, GCP ClinPlus is a trusted partner for advancing non-traditional health products to market—safely, efficiently, and compliantly.
