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API & Intermediates CDMO Service

Clinical Formulation Development Service

We have facilities, equipment, and instruments to develop various dosage forms including tablet, capsule, particulate, ointment, cream, gel, injection, and oral liquid. In addition, we are highly skilled in developing complex dosage forms including but not limited to various control released dosage forms, nanocrystal formulation, microemulsion, and others. Additionally, we have more than ten GMP suits that can manufacture drug products to support the pre pivotal clinical studies. 

Our employees in drug product R&D are highly educated, experienced, and knowledgeable in pharmaceutical dosage form development. We define drug product QTPP, CQA and then follow the QbD strategy to perform risk assessment, risk characterization, and finally provide the risk mitigation and control strategies for commercial manufacturing and launch.   

We have the capability to develop but not limited to the following dosage forms
Oral formulations and dosage forms
(1) Solution, Suspension;
(2) Tablet: Immediate/control released tablet, Oral disintegrating tablet, Chewable tablet, Effervescent tablet, Bilayer tablet, Mini-tablet;
(3) Capsule: liquid, powder, granules, pellets, and/or tablets in hard gelatin or HPMC capsule;
(4) Particulate: Single or combination of multi type of particulates;
(5) Drug in bottles or in capsules;
(6) Powder blend in bottles or in capsules;
(7) Powder in Sachets;
(8) Enteric drug delivery;

 Injectable formulations and dosage forms
(1)Solution;
(2)Suspension;
(3)Microemulsion;                                                                                                                                                    (4)Nanocrystal; 
(5)Complexation; 
(6)Microsphere; 
(7)Lyophilization powder;
(8)In-situ gel;

Formulation and dosage form for other delivery routes
(1) Cream, Ointment;
(2) Ophthalmic dosage form;
(3) Transdermal patch;