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.