ENG
Solution & Service
Clinical Drug Product R&D Services

We have facilities, equipment, and instruments to develop various dosage forms including tablet, capsule, particulate, ointment, cream, gel, injectable, suspension, oral liquid, and others. In addition, we are highly skilled in developing complex dosage forms including but not limited to various control-released dosage forms, nanocrystal formulation, microemulsion, amorphous solid dispersion 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, and CQA and then follow the QbD strategy to perform risk assessment and 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 delivery preparation

Solution, suspension

Tablet: immediate/control released tablet, oral disintegrating tablet, chewable tablet, effervescent tablet, bilayer tablet, mini-tablet

Capsule: liquid, powder, granules, pellets, and/or tablets in hard gelatin or HPMC capsule

Particulate: Single or combination of multiple types of particulates

Drug in bottles or capsules

Powder blend in bottles or capsules

Powder in sachets

Enteric drug delivery

 Injectable formulations and dosage forms

Solution

Suspension

Microemulsion

Nanocrystal

Complexation

Microsphere

Lyophilization powder

In-situ gel

Formulation and dosage form for other delivery routes

Cream, ointment

Ophthalmic dosage form

Transdermal patch