"The breadth of services we offer enables us to work with companies of all sizes. Our passion is to understand their requirements and ensure that they receive the right level of quality support from our team"

Julie Beal, Company Owner

our tailored and flexible QA services
 
In addition to auditing, we provide a full range of QA services including:
 
consulting on risk management and audit programmes

Risk management is an important part of planning for any business. We can help advise you on your strategy and in the development of your audit programmes to ensure that your business meets its obligations in a cost-effective and compliant manner.

 
establishing pharmacovigilance systems

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, conducting audits, providing bespoke training courses, inspection readiness, quality management system development and review, and offering ad hoc advice.

 

training

Training is essential to the development and sustainability of a business. We provide training in all aspects of QA, including across the GXPs (GCP, GVP, GMP, GDP, GCLP and GLP). We can provide you with insight into EU, US FDA, WHO,  ICH or other international guidance and regulations to meet your needs.

 

inspection readiness and support

We have extensive experience helping companies of all sizes preparing for their regulatory inspections or other third-party audits. We can help you with every aspect of the inspection process from full mock inspections, mock interviews, training and CAPA management to inspection hosting, scribing and post-inspection support.

 

gap analysis

Zigzag can assess your existing QMS to determine the areas of deficiency, and provide pragmatic solutions to help you bridge these gaps. Ultimately, this will ensure an effective and robust QMS to ensure your business is compliant and efficient.

 

QMS development

Clinical trials and positive regulatory inspections in the different GXP areas rely upon the effectiveness of your QMS. From a detailed assessment of your company, we can provide strategic advice in identifying the QMS that will meet both your business and compliance needs.

 

SOP writing and review

We offer our clients full support with every aspect of their SOP development.  If you are looking for help to write a new SOP, or are looking for help to review or harmonise your existing SOPs, Zigzag has the expertise to help you through this process.

 

CAPA management

Managing the CAPA process effectively and efficiently is essential to ensure process improvements. Our team can offer support on how best to manage your CAPA system to ensure that actions are properly recorded and addressed in a timely manner.

 

in-house support

At Zigzag we understand that you may require additional resource during times of peak activity or whilst you are trying to recruit. Should you require in-house QA support, our experienced professionals can help on short or potentially long-term placements to support you when needed.

 

ad hoc consultancy

In addition to the above we also offer help and advice relating to QA regulatory requirements. Our advisory service is designed to complement your QA team or, if needed, to entirely support your company when it does not have its own in-house QA resource to call upon.

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Steve Keys

Abbreviations:

 

Good Clinical Practice - GCP, Good Vigilance Practice - GVP, Good Manufacturing Practice - GMP, Good Distribution Practice - GDP, Good Clinical Laboratory Practice - GCLP, Good Laboratory Practice - GLP, Pharmacovigilance - PV, Computerised System Validation - CSV, Quality Management System - QMS, Standard Operating Procedures - SOP, Quality Assurance - QA

 

Europe: t. +44 1235 854033 | Singapore: t. +65 6408 3766 | USA: t. +1 617-401-2630

e. info@zigzagassociates.com | Zigzag Associates Ltd

 Registered Office: The White House, Mill Road, Goring on Thames, Reading, Berkshire, RG8 9DD, UK

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