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CDMO SERVICE
15 Years of Excellent Service in Pre-formulation and Formulation
Polymorph and Crystallization Topical & Transdermal Delivery Complex Generics Accelerated FIH Development GMP Manufacturing Analytical Testing
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Accelerated FIH Development
Specialities
FIH Development Accelerator – NCE Molecules
FIH Development Accelerator – 505(b)2
Regulatory Filing to Multiple Authority Agencies
Specialities

●  Formulation Development for Poorly Soluble Drugs

●  Formulation Development for Poorly Permeable Drugs


●  Formulation Development for Reactive Molecules


FIH Development Accelerator – NCE Molecules

●  5 years of Excellent Service Experience in Preformulation & Formulation

 

●  Our library of 200+formulation protocols allow for rapid selection of optimal drug delivery systems based on molecular physiochemical properties.

 

●  Streamline collaboration with partners to expedite FIH development and meet the 12-month submission target.


FIH Development Accelerator – 505(b)2

●  Assessing Clinical Advantages of Product Design Concepts

 

●  Proprietary Technology for Enhanced Topical and Transdermal Drug Delivery

 

●  20+ Animal Models for Preclinical Dermatological Evaluation


Regulatory Filing to Multiple Authority Agencies

●  Expertise in Global Regulatory Landscapes: NMPA, FDA, and EMA

 

●  Bilingual (Chinese and English) Technical Reports and Dossiers

 

●  Proven Track Record for Navigating the China and US Regulatory Pathways