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.
Develop SOPs covering all GxPs
Develop QA SOPs
GxP SOP gap analysis
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.Author Name
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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.