Montrium offers an SOP writing and review service to assure compliance with the current GxP requirements based on an initial Gap Analysis. Montrium can assist in the preparation of SOPs that support the ongoing activities of our clients in addition to providing guidance for the implementation or revision of SOPs and forms to ensure compliance with regulatory requirements. We can also provide standard templates of SOPs, forms and checklists developed in compliance with ICH guidelines, FDA CFRs, EMA directives, Health Canada regulations and industry standards.
We have experience implementing and reviewing SOPs for the following:
- Clinical Data Management
- Quality Assurance
- Information Technology and Computer Systems Validation
Please contact us to learn more about the specific SOP services you are interested in.