Standard Operating Procedure Development

Whether it’s a completely new set of SOPs or a comprehensive assessment of SOPs against current practices ADAMAS has the expertise to help you. Our consultants understand what makes a good procedure work.

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Develop SOPs covering all GxPs

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Develop QA SOPs

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GxP SOP gap analysis

Find out how ADAMAS Consulting can help with your next project

Recent examples of our work:

Preparation of a complete set of clinical development SOPs for a Japanese company undertaking studies in Europe and the USA.

Gap analysis of a US client’s SOPs against European regulatory requirements, including amendments to bring them into compliance.

Developed SOPs for IT company providing software for clinical trial

ADAMAS Consulting can also conduct reviews and updates of existing SOPs to achieve compliance with ICH GCP, European and US regulatory requirements. ADAMAS Consulting’s SOP development process involves the preparation of a development plan, which is agreed with the client prior to initiating interviews with key staff and the development of process maps.

Thank you very much for the updated final draft of CLxxx. With it, we have completed the first stage of our QMS. I do think it could not be achieved without your and your colleagues’ generous cooperation. With our very best wishes for the Christmas and New Year period and looking forward to working with you in the year to come.

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We have 500+ years combined experience, working around the globe there isn’t anything we’ve not encountered in our sector. We're very approachable and happy to help.

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The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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How to be a Clinical Auditor

 

‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

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Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

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Is your QMS compliant?

 

Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

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ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

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