Tergus Pharma is an end-to-end contract service provider for topical pharmaceutical products supporting early phase research and formulation, drug development, testing, and both clinical and commercial manufacturing at our 100,000 sq. ft. state-of-the-art facility in Durham, NC. Tergus is the industry leader for topical semi-solids and liquids for skin, nasal, otic, ophthalmic, vaginal, and rectal routes of administration. Exclusively focused on topical development and manufacturing, Tergus brings the scientific expertise that helps our clients achieve the right balance of scientific knowhow, speed of results, and quality, warranting our company motto, “Think Topicals, Think Tergus.”
Tergus is a pioneer in topical pharmaceuticals
We are a pioneer in IVRT testing, and have amassed one of the largest bank of IVRT Franz Diffusion cells in the world. 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 the intellectual power to accelerate your drug delivery timeline.
Tergus Pharma is also a pioneer in using Quality by Design (QbD) principles for the development of 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. Our team is supported by well-equipped labs that are fully compliant with cGMP and ICH requirements.
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 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 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.
Quality & Compliance
Tergus Pharma possesses the knowledge to help you navigate the regulatory requirements and determine the best development path. With our collective expertise in topicals, you can be confident that the processes and data that we deliver to you will help ensure a successful and on-time project.
Tergus is registered with the FDA as a contract research organization and complies with relevant national and international regulations and guidelines of Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). Additionally, the Tergus quality team is managed independently from all other organizational units and is responsible for providing objective quality and regulatory counsel. The team performs regular surveillance checks and audits on both internal and third-party GxP material and service providers to ensure compliance with appropriate regulations, and to maintain standards of quality and integrity throughout the organization.
Tergus is dedicated to maintaining experienced team members who are devoted to a level of quality and compliance that supports and safeguards ourselves and our clients.
INDEPENDENT
The Quality Unit is managed independently of all parties to assure no conflict of interest regarding the approval of material disposition and documentation services.
COMPLIANT
Tergus is compliant with relevant local, federal, applicable international regulations and guidelines governing current Good Laboratory Practice (GLP: 21 CFR 58), Good Manufacturing Practice (GMP: 21 CFR 210 & 211) and Good Clinical Practice (GCP: 21 CFR 312 & 812)
QUALITY BY DESIGN
From formulation development through manufacturing, Quality by Design (QbD) objectives are used to ensure that all processes are consistent and produce quality results.
Culture of Quality
Quality begins with me
RISK MANAGEMENT
Tergus helps you manage risk in way that is right for your specific development and manufacturing needs through our depth of experience and robust quality systems.
CONTINUOUS IMPROVEMENT
Tergus provides a development environment and manufacturing process that permits ongoing controlled changes for continuous quality improvement.
TRANSPARENCY
Tergus strives to provide you with consistent and constant communication regarding project governance and execution.
CONTACT US
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