Mtech consulting group (Mtech) provides a wide variety of services to help pharmaceutical companies meet International Regulatory challenges. Our team members specialize in guiding pharmaceutical companies to establish efficient, cost-effective and quality systems, which will pass inspection and produce high-quality products.
Mtech consultants have varied expertise in all aspects of Quality, from writing SOPs, protocols and Master Plans needed to set up a new manufacturing facility to reviewing existing systems for compliance, effectiveness and efficiency. The pool of experts includes specialists in auditing (including extensive international experience with a practical knowledge of specific European regulatory requirements), process validation, computer validation (including 21 CFR Part 11 compliance), equipment qualification, utility and environmental monitoring, microbiology issues, and all aspects of manufacturing. We have helped our clients to achieve Operational Readiness and create Business Efficiencies while meeting their Compliance needs.
All Mtech consultants come from biopharmaceutical backgrounds and have worked successfully with many traditional pharmaceutical and biotech clients. We have an unrelenting passion to deliver brilliant client service, one of the core values of our firm. We have worked with our clients to deliver high-impact results for business challenges and goals with delightful results for our clients.
- If you have a quality systems that needs implementation but are short on staff or experience, we can help you start it or fully implement it
- If you are concerned about compliance at your contract manufacturer, laboratory, or raw material supplier, we can help you assess them
- If you think now is too early to think about Process Validation, think again. The more thought you put into defining your product and process early on, the more money and time you will save in getting to market. Start now. We can show you the critical things to consider to make this complex project much easier
- If your existing quality systems is too cumbersome and labor intensive, we can provide alternative systems or reengineer the system
- If you have validation or qualification projects that need to be completed ASAP, we can jump in and get it done
- We can help you significantly reduce the time and resources required to complete your projects. Contact us today to discuss your needs
