One of the most consistent FDA inspection findings in the last few years has revolved around inadequate processes, a key aspect of which is SOP infrastrcuture.
At MVG, ensuring our clients have a robust, inspection-ready suite of SOPs is a top priority. Our team works closely with clients to ensure their Standard Operating Procedures (SOPs):
- Are uniformly written with detailed instructions to record routine operations, processes and practices followed within a business organization
- Contain adequate detail to clearly guide research staff through a particular procedure
- Are aimed at a specific procedure but be written in a general format that can be easily followed so as to avert procedural deviations
- Reference applicable guidances and regulations within the SOP, such as ICH E6 Good Clinical Practice and 21 CFR 50
- Have processes established for distribution, education and training on new departmental SOPs to ensure compliance
If your SOPs are in need of review, MVG Consulting is the perfect resource. Our highly skilled consultants will meet with your team to determine your specific project needs and from there will tailor your SOPs accordingly. Because our projects follow a “fit-for-purpose” model, you can be assured that your SOPs will accurately reflect your company’s internal processes and procedures.
MVG Consulting Services specializes in helping small to medium sized biotechnology and pharmaceutical companies with their clinical development programs and we can provide start-up and virtual companies with the necessary resources to begin their clinical development program.
Services include:
- Clinical Research Consulting Services
- Clinical Trial Development
- Project Rescue
- Inspection Readiness
MVG provides highly qualified clinical research professionals who seamlessly become a part of your project team. Additionally, we provide virtual companies with an entire project team that encompasses all aspects of clinical development.
We invite you to fill out the form below to learn more about how MVG Consulting can help you with your clinical devleopment needs.
