Tergus, an end-to-end service provider for topical pharmaceutical research, drug development, testing and manufacturing company, has been an industry leader for several years with a state-of-the-art facility in Durham, North Carolina. The company has a long and stellar reputation for delivering quality results to clients from formulation through manufacturing, which is why people say, “Think Topicals, Think Tergus.”
We excel in IVRT testing, having one of the largest bank of IVRT Franz Diffusion cells in our labs. Our industry experts develop exceptional testing protocols, work on new APIs to provide you with outstanding results. Being the leader in drug development for semi-solids, we bring forth intellects to accelerate drug delivery for you.
Tergus Pharma pioneered QbD (Quality by Design) for topical drugs. Our staff is focused on quality and compliance and includes industry leaders and experts in topical development, formulation, analysis, testing and clinical supply manufacturing. This is facilitated by the well-equipped labs fully compliant with cGMP and ICH requirements, and studies compliant with the FDA.
A systematic and scientific approach is used to thoroughly understand product components, processing, and finished product attributes to ensure high quality product throughout the course of development. We can help you achieve a balance between a fast-tracked program and quality science
quality Target Product Profile (qTPP):
Tergus scientists will work with you to establish a qTPP. The target product profile identifies critical parameters that will impact product quality. This includes, but is not limited to, dosage form, target strength, aesthetics, and shelf-life.
Critical Quality Attributes (CQAs):
Physical, chemical, or biological characteristics that can be defined and measured over time to confirm product quality. From evaluation of CMAs and CPPs during formulation development to manufacturing of clinical supplies and stability testing, Tergus is your one-stop shop for quality by design. Our teams understand the nuances of semi-solids and work with you to monitor CQAs and troubleshoot as needed.
Critical Process Parameters (CPPs):
Manufacturing processes that should be within a specified range to ensure product quality. At Tergus, we take care to evaluate the manufacturing process from bench to large-scale as these parameters can significantly impact emulsion stability. Our manufacturing facility has 5 vessels that are directly scalable, thereby minimizing risk as your clinical needs change.
Critical Material Attributes (CMAs):
A physical, chemical, or biological characteristic of an excipient that should be within a specified range to ensure product quality. Tergus has several quantitative tools, such as rheology and viscosity, to evaluate topical excipients and understand the impact of these material characteristics on the final product, resulting in a robust formulation.