Services

Our team have extensive hands-on experiences in developing more than a dozen of different biopharmaceutical products to reach FDA marketing approval (ANDA, NDA and BLA), ranging from small molecule therapeutics to viral vectors and covering various dosage forms and drug-device combinations. 

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

We provide consulting and lab services in:

• Preformulation/characterization of API and biologic drug substance including mAbs, ADCs, viral/non-viral vectors (Adenovirus, AAV, Lenti Virus, Plasmid, mRNA)
• Formulation development for small molecule therapeutics and biologics including mAbs, ADCs, viral/non-viral vectors (Adenovirus, AAV, Lenti Virus, LNPs)
• Analytical method development/validation/tech transfer
• Product manufacturing process development/qualification/tech transfer
• 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/testing allows us to effectively work with CDMOs in product manufacturing and testing to meet our clients' 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