Copyright © 2025 Shenyang Dasan Pharmaceutical Technology Co., Ltd.
Full-chain capabilities from chemical R&D to global collaboration, powered by five synergistic segments
delivering one‑stop solutions that reduce communication costs and strengthen the brand.
Consistency Evaluation · Generic R&D
Advanced Formulation Development
Full-process Regulatory Support · Document Review & Translation
NMPA Communication Agency
Clinical Site Coordination · Protocol Design Optimization
Full-service CRO Support
MAH + Multi-country Filing
Domestic Agent (DA) for Overseas Pharmaceutical Companies
Partnering with top Korean research institutes to develop and sell health and advanced beauty products.
We offer consistency evaluation for oral solids and injections – BE, packaging compatibility, stability – to help clients clear procurement thresholds and boost competitiveness.
With multi-dosage scale-up and regulatory writing experience, we accelerate generics from IND to ANDA, shortening R&D time, lowering costs, and improving market responsiveness.
Focus: controlled-release, pediatric, geriatric. Solutions: taste‑masking, microparticles, osmotic pumps. Designed for special needs, better experience.
Registration of Imported Drug Products/APIs/Excipients/Packaging Materials
Gap Analysis & Dossier Preparation
Customized Study Support
Clinical Trial Assistance & Oversight
Full NMPA Communication & Post-approval Management
Clinical Trial Approval Obtained
API Registered & Publicly Disclosed
Leveraging the latest NMPA guidelines and employing strategies such as population pharmacokinetics and adaptive design to ensure scientifically sound clinical trial protocols and improve first-pass approval rates.
Maintaining annual cooperation frameworks with over 30 GCP centers, enabling rapid subject recruitment and ethics approval, providing efficient resource support for clinical trials.
Equipped with dedicated monitoring, data management, and biostatistics teams, covering BE, Phase I-III, PK/PD, and human food trials, ensuring high-quality project delivery.
Service cases span diverse types including generic drug combination BE studies, preclinical trials for novel anti-gout drugs, and health food human trials, demonstrating cross-therapeutic area delivery experience across various registration categories.
Leveraging the Marketing Authorization Holder system to build cross-border collaboration ecosystems, flexibly matching assets at different stages with funding needs.
Technical Synergy: Integrating complex formulations, process transfer, and stability management to meet multi-country filing requirements.
Manufacturing Synergy: Rigorously selected CMOs, on-site quality oversight, and dual-release to minimize quality risks.
Commercial Synergy: Leveraging in-house marketing networks and partner channels to achieve full coverage in tenders, hospital listings, and retail.
Co-License-in + MAH
MAH + Multi-country Filing (China data for US/EU submissions)
Technology Licensing + MAH (Technology transfer + sales royalty)
Domestic Agent (DA) Services for Overseas Pharmaceutical Companies
Backed by top Korean research institutes, focused on brain nutrition and anti-fatigue. Building strong technical advantages.
Strong R&D and clear market strategies to create diverse, innovative products that deliver real results.
Aiming to lead the health and beauty industry, creating better, healthier lives for consumers.