Global Drug Registration
NMPA/FDA/EMA IND, NDA, BLA and CTA filings, eCTD compilation and regulatory communication.
Insights for Pharmaceuticals
Empowering Global Drug R&D
Registration-led development strategies for regulatory approval, clinical development and research translation.
20+Years of average expert experience
30+Global filing projects delivered
10+Formal CDE consultations
CN/US/EUMulti-region regulatory support
Flagship Product
Regulatory Intelligence
A regulatory AI agent for drug registration, clinical development and global filing strategy, integrating guideline search, filing pathway assessment, agency meeting preparation and project GAP analysis into one efficient workflow.
- Regulatory guideline and technical document search
- IND / NDA / BLA / CTA filing pathway assessment
- CDE / FDA / EMA meeting package preparation
- Project GAP analysis and key risk flagging
Company Profile
An external expert team for critical drug R&D decisions
InsPhar is a professional medical technology service provider specializing in regulatory affairs, clinical development, and drug R&D strategy.
Adhering to the core philosophy of "R&D from a regulatory perspective," we provide end-to-end solutions for pharmaceutical enterprises worldwide, from drug discovery to product launch.
Our mission is to help clients save R&D costs, accelerate global filings, and improve project success rates.
Core Services
Integrated regulatory, clinical and R&D strategy support
Comprehensive strategic and execution support across China, the US and Europe.
Clinical Development Strategy
TPP building, Phase I-IV trial design, international multi-center and bridging studies.
China Regulatory Affairs
Regulatory consulting for foreign companies conducting R&D, registration and clinical activities in China.
GAP Analysis
Assessment between regulatory requirements and project status to map the optimal development path.
PCC Selection & Discovery Strategy
Multi-dimensional property screening, TPP index establishment and early risk warning.
Investment & BD Empowerment
Technical due diligence, project valuation, business negotiation support and licensing assistance.
Cooperation Models
Flexible models that function like your external R&D department
On-demand access to senior experts without the cost burden of a full fixed-function department.
01
Full-cycle Project Turnkey
One-stop, fully managed service from initiation, R&D and registration to launch.
02
Modular BPO Outsourcing
Flexible modules covering registration, clinical strategy, FTO analysis and PCC evaluation.
03
Virtual R&D Director
Senior experts serve as part-time technical advisors for key project decisions.
Selected Success Stories
Resolving filing challenges through scientific strategy
Over 30 pre-IND / IND / NDA / BLA global filing projects and more than 10 formal face-to-face consultations with CDE.
Rapid Domestic Approval for Foreign Urgent Drugs
Successfully persuaded CDE to waive local trials through ethnic sensitivity analysis, enabling direct marketing approval and a significantly shortened launch cycle.
Waiving PK Bridging Study for HBV Drug
CDE approved the bridging study waiver after scientific multi-center data analysis and special consultation, directly supporting IND approval in China.
US FDA ODD Designation for Rare Disease Drug
Secured FDA orphan drug designation, unlocking policy support, development advantages and future commercial value for the program.
Conditional Approval Pathway for Rare Mutant Tumor Drug
Aligned unmet medical needs with early efficacy data and enabled CDE approval of a Phase II single-arm study across KR/CN/US development planning.
Strategic Breakthrough for Nectin-4 ADC in UC
Designed a differentiated pathway targeting platinum-intolerant patients, bypassing competition barriers while reducing clinical development cost and risk.
Full-Cycle R&D for Antibacterial Registration
Optimized the non-clinical-to-clinical development pathway, completed core studies efficiently and advanced the product to the filing stage.
Full Indication Extrapolation for an Autoimmune Biosimilar
Optimized the non-inferiority margin, aligned with CDE through in-depth communication and supported Phase III resumption and full extrapolation.
Technical Advantages in Biosimilar Development
Built a quality-control system based on 50+ biosimilar projects, supporting key quality consistency, trial exemption discussions and faster market access.
Contact Us
Partner with us to create a new chapter in pharmaceutical R&D
Email: ytx@insphar.com
Innovation Building, Zhongguancun Life Science Park, Changping District, Beijing, China.
