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Quality Assurance Services
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| In addition to providing quality oversight of Regulus’s work product, Regulus QA provides expert quality assurance services to pharmaceutical, biotechnology, and dietary supplement companies. Whether you are looking to develop and implement quality systems from scratch, or need to standardize and review the compliance of your existing systems, or your contractors’ systems, Regulus QA’s experienced team of auditors and QA professionals can help you. |
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| GxP System Audits |
| In a detailed assessment of your quality systems and processes, we will highlight problem areas and recommend improvements, so you can be sure you have everything covered right from the start. We can also conduct similar activities on your behalf for third-party contractors. The audits will be tailored to your particular GxP needs with an understanding of the spectrum of requirements across all stages of product development. Regulus can also assist you in preparing for Regulatory Authority inspections, including FDA’s pre-approval inspections of manufacturing facilities. |
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| GCP Project Audits |
| We conduct GCP audits of protocols, investigator sites, master files, pharmacovigilance, databases and reports for a wide variety of clinical studies. With our expertise you can be sure that quality is maintained at every stage |
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| GxP Training |
| It is important to make sure that everyone in your team understands the relevance of quality systems and knows how to apply them to projects. With our extensive experience, we can provide training in all aspects of GxP, providing insight into EU, US FDA, WHO, OECD or ICH guidance and regulations to meet the needs of your specific project. |
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| Laboratory Services |
When using laboratories, whether research (non-GLP), pre-clinical (GLP), clinical (GCLP) or commercial product QC support (GMP) laboratories, you need to be sure that the data is credible and is in compliance with protocols, SOPs and regulatory requirements. Regulus QA can provide a comprehensive range of auditing services for all laboratories.
We can also offer expert advice and guidance in laboratory quality issues, assisting with the establishment of quality management systems, the preparation of laboratory policies and SOPs, and the planning of routine monitoring and QC procedures. |
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| Manufacturing Services |
Throughout the development of your product, it is essential to ensure that regulatory requirements are being strictly observed. Regulus QA can coordinate the conduct of GMP audits of process development and formulation laboratories, as well as manufacturing and packaging facilities. Regulus QA can then assist you in completing post-audit follow-up actions in response to a Regulus, regulatory or third-party audit by providing project management, SOP writing and system implementation services to best fit your timelines and requirements.
Our professionals bring their direct experience in small molecule, biologic, and drug substance manufacturing to help you with your QA needs at every stage of product development. Regulus QA can coordinate the quality aspects of projects ranging from process improvements to “ greenfield” construction including facility design, construction and commissioning using direct staff and preferred subcontractors with the facility and equipment validation experience needed to make projects of any size a success.
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