GxP Auditing & Quality Assurance

We provide expert Quality Assurance consulting services to pharmaceutical, biotechnology, medical device, and dietary supplement companies to help ensure they are in compliance with current business practices and regulations. Our team of auditors can perform a detailed assessment of your existing quality systems and processes, to highlight problem areas and recommend improvements, so that you can build quality systems that are appropriate for your company’s stage of development. We can assist you with all aspects of compliance, as they impact your product, including GLP, GMP, QSR, and GCP.

Our QA team also offers a comprehensive range of auditing services for laboratories to meet global GLP and GMP requirements. We also offer expert advice and guidance in laboratory quality issues, assist with the establishment of quality management systems, the preparation of laboratory policies and SOPs, and the planning of routine monitoring and QC procedures. In addition, we can conduct GMP audits of process development and formulation laboratories, as well as manufacturing and packaging facilities. We can also conduct similar activities on your behalf for third-party contractors.

GxP Auditing Services

System Audits

We can perform a detailed assessment of your quality systems to assist you in preparing for Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Quality System Regulations (QSR) inspections by Regulatory Authorities, clients and corporate partners. Our experience covers biotechnology (including cell and tissue-based therapeutics), pharmaceutical and medical device companies. Additionally, our team conducts compliance audits and assessments of your third-party contractors and vendors; and will assist you in preparing for regulatory authority inspections, including FDA pre-approval inspections of manufacturing facilities.

Clinical Trial Audits

In addition to system audits, our team conducts study-specific 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 of your clinical trial.

The audits will be tailored to your particular compliance needs and relevant for the stage of product development. Our QA team have performed audits in the US, Canada, Europe, Asia, and Pacific Rim.

Laboratory Audits

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.

Our QA personnel provide a comprehensive range of auditing services for all types of laboratories. We 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 Quality Control analytical test procedures.

Manufacturing Audits

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. We 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.

Our team coordinates the conduct of GMP audits of process development and formulation laboratories, as well as manufacturing, distribution and packaging facilities.

Additionally, we assist clients in:

GxP Compliance 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 your programs. With our extensive experience and well-qualified personnel, we can provide training in all aspects of GLP, GMP, QSR, and GCP providing insight into European, US FDA, WHO or ICH guidance and regulations to meet the needs of your specific project.

Standard Operating Procedures

We can write standard operating procedures for your specific compliance needs, whether they are GLP, GMP, QSR, or GCP. We will work with you to implement the SOPs and provide training in their use. Clinipace can also provide Quality Manuals for your organization.

News

Regulus acquired by national firm

Boutique consulting firm Regulus Pharmaceutical Consulting Inc. in Boulder has been acquired by national clinical research firm Clinipace Worldwide. Terms of the deal were not disclosed. The Regulus team of approximately 15 people will remain in Boulder, said David Levin, a Clinipace spokesman.

Morrisville’s Clinipace buys Colorado company

Clinipace Worldwide, a global digital clinical research organization based in Morrisville, has closed on the acquisition of Regulus Pharmaceutical Consulting Inc., a regulatory affairs and quality assurance consultancy based in Boulder, Colo.
Financial details were not disclosed.

Clinipace Worldwide
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