Services

Quality Assurance Methods to Deliver Better Outcomes

GxP auditing is just one piece of implementing a quality management system (QMS). To attain and maintain compliance with local and international regulations, you must also manage training, documentation, problem solving, changes in regulation, standard operating procedures (SOPs) and more — you must have effective quality assurance (QA) methods.

Partner with ZigZagQA for dependable, expert QA services that open up a world of enhanced quality.

Comprehensive Services to Support Your QA Needs

Audit Services

Auditing every phase of the drug development process in all locations.

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Consulting

Strategy, management & efficiency.

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Site Quality Assessments

Mitigating the risk of site selection and usability.

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ZigZagQA is a trusted global leader in QA management, offering true global reach and unrivaled expertise to reduce risk and efforts. Working as an extension of your team, our experts increase your capability and efficiency with collaborative, comprehensive and customized QA programs that also encompass supporting services such as:

An efficient and effective CAPA process is essential to process improvements. Our team can offer support on CAPA management to ensure that actions are properly recorded and addressed in a timely manner.

We have extensive experience helping companies of all sizes prepare for regulatory inspections or other third-party audits across all GxPs, from storyboard development, mock interviews and corrective and preventative action (CAPA) management to inspection hosting, scribing and post inspection support.

We reserve our most experienced auditors and ex-FDA inspector partners for our inspection readiness and regulatory inspection management services, including inspection readiness audits, site readiness visits and mock inspections tailored to the pertinent regulatory agency. We also conduct inspection readiness programs for sponsors in good clinical practice (GCP), pharmacovigilance (PV), good manufacturing practice (GMP), good laboratory practice (GLP) and more.

ZigZagQA can assess your existing QMS to determine the areas of deficiency and provide pragmatic solutions, helping you establish and/or maintain an effective and robust QMS to ensure your business is protected, secure and safe.

From a detailed assessment of your company, we can provide strategic advice in identifying the QMS that will meet your business and compliance needs.

We offer our clients full support with every aspect of their SOP development, whether that means helping write a new SOP or reviewing existing SOPs.

Training is essential to business development and sustainability. We offer training in all aspects of QA management and can provide you with insight into European Union (EU), USA Food & Drug Administration (FDA), World Health Organization (WHO), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and other international QA standards and regulations.

At ZigZagQA, we understand that you may require additional resources during times of peak activity or recruitment. Our experienced QA professionals can help with short- or long-term placements.

Our experience in pharmacovigilance (PV) allows us to provide our clients with full PV support, including establishing PV systems for drug development and marketed products, providing bespoke training courses, assisting with inspection readiness, developing and reviewing QMS and offering ad hoc advice.

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