Services

Our team have hands-on experience in developing dozens of different drug products and dosage forms, ranging from small molecules to biologics and covering areas of oral solid, nasal spray, sterile injectable, and ophthalmic products. 

We provide services in:

• Preformulation/characterization of API and biologic molecules
• Formulation development for small molecules and biologics
• Analytical method development and validation
• Product manufacturing process development
• Stability studies

We have established a systematic approach to facilitate effective technology transfer from R&D labs to CMOs or between two CMOs, minimizing the time to provide drug product supplies in clinical/ANDA development or in commercial activities.

We have identified and established good relationships with a list of FDA inspected CMOs in the US and abroad, capable of manufacturing APIs/biologics, and various final dosage forms (including oral, nasal spray, inhalation, and/or sterile liquid/suspension/lyophilized powder dosages) with competitive timelines and pricing for clinical supply and/or commercial production. Our extensive experience in managing outsourced contract manufacturing and testing allow us to effectively work with the CMOs in manufacturing and testing of products to meet specifications and timelines. 

 We provide our clients the following services: 

• Composing the CMC and summary sections of an application (DMF, IND, ANDA, NDA, and BLA)
• Publishing submissions in the eCTD format
• Reviewing technical documents and/or submissions for compliance with current FDA’s expectations and regulations
• Providing regulatory strategies on product development and manufacturing
• Assisting in FDA meetings, and in preparation of manufacturing facility for FDA on-site inspection

As a US agent, we offer a cost-effective pathway to foreign pharmaceutical companies who are interested in entering the US market, and we assist our clients in the following areas:

• Product (API and/or final dosage form) establishment registration with US FDA
• Drug listing with US FDA
• Obtaining labeler code, and complying drug labeling with US FDA regulations