Services

Our team have hands-on experiences in developing more than a dozen of different bio-pharmaceutical products to reach FDA's marketing approval (ANDA, NDA and BLA), which ranged from small molecule therapeutics to viral vectors and covered various dosage forms including oral solid, nasal spray, and sterile injectable products. 

We specialize in developing stable formulations (solutions, suspensions or lyophilized dosages) for unique administration routes such as intrathecal/intravitreal injection and intranasal/inhalation dosing, besides conventional IV, IM and SQ administration. 

We provide consulting and services in:

• Preformulation/characterization of API and biologic drug substance including viral/non-viral vectors (Adenovirus, AAV, Lenti Virus, Plasmid, mRNA)
• Formulation development for small molecule therapeutics and biologics including viral/non-viral vectors (Adenovirus, AAV, Lenti Virus, LNPs)
• 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 CDMOs or between two CDMOs, 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 CDMOs in the US and abroad, capable of manufacturing APIs/biologics/plasmids/mRNAs/viral vectors, and various final dosage forms including oral solid, nasal spray, inhalation, or sterile injectable (liquid/suspension/lyophilized powder) dosages with competitive timelines and pricing for clinical supply or commercial production. Our extensive experience in managing outsourced contract manufacturing and testing allow us to effectively work with the CDMOs in manufacturing and testing of products to meet specifications and timelines. 

 We provide our clients with consulting and the following services: 

• Regulatory strategies on drug product development, manufacturing and testing
• Composing the CMC and summary sections of regulatory dossiers (DMF, IND, ANDA, NDA and BLA)
• Reviewing technical documents and submissions for compliance with current FDA's guidelines and regulations
• Publishing regulatory submissions (DMF, IND, ANDA, NDA and BLA) in the eCTD format
• 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/drug substance 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