In order to gain an FDA approval, safety and efficacy of the new drug or drug product must be proven through use of supporting scientific evidences. The demonstration of proper control and validation of processes and controls undertaken must be done to ensure that the product meets the established standards of quality.
We take part on several preclinical to clinical testing to determine efficacy of medical drugs and substances.
Our dedicated scientist can serve as your partner from lead optimization to commercialization for your next advanced therapy.
For those customers that require enhancing the half-life and stability of their final drugs or
bioactives, we offer cutting edge formulation services using encapsulation technology that are based on biocompatible polymers, polysaccharides, and other macromolecular or lipid-based carriers.
Our scientific and bioengineering teams have the knowledge and years of experience to support our clients with different encapsulation approaches during R&D, drug development and manufacturing for several applications.
Our manufacturing facilities are world-class built in accordance to PIC/s and HSA CTGTP guidelines. we develop the full process validations, product characterization, and production for all clinical trial phases.
Our fill and finish services cater to preparations in which the end product is in liquid, cell, or vial form. This production of clinical trial ready product can be done in a ready-to-use vial filling line with integrated freeze drier integrated in an isolator. The same cGMP-compliant process can be applied
to client’s dosage, formulation and filling requirements defined in the dossier submission package.