With over 11 years of experience in Compliance Consulting and serving over 30 clients, Mtech is a leading provider of the US FDA Regulatory Compliance services in the United States and abroad. Our goal is to help our clients set up a solid foundation while minimizing potential risk through approval or compliance process.
Compliance with US FDA regulations is the surest way to dramatically increase the value of your products and to expand to the global market. Failure to comply with FDA regulations in a timely manner can impact serious financial consequences as well as irrevocable damages on the corporate image. Particularly the last year’s imports alone, the FDA refused more than 15,500 products from abroad, and this strict screening process is expected to continue.
We work with our clients to design and implement effective and efficient business processes that assure sustainable compliance and we do so through optimal integration of scientific, technical, and regulatory principles. Equally as important, we help our clients stay current with the ever-changing regulatory and technical environment, as well as with evolving industry practices.
Mtech’s Compliance Practice works with a diverse base of companies and is proud of what we've accomplished with our clients. The list below provides a high-level overview of the results we've delivered and how we can support your needs, as well:
- Performed third-party oversight for single-site and multi-site consent decree remediation
- Facilitated the vacating of consent decrees involving sterile and non-sterile products
- Provided expert consultant services for development and execution of numerous remediation/voluntary corrective action plans, which have been accepted by the FDA
- Provided numerous due diligence activities during the pre-purchase phase for multinational companies and marketing applications
- Performed numerous application integrity audits
- Facilitated numerous new facility construction reviews for pharmaceutical clients with the FDA
Our compliance consulting services offer one of the most extensive networks of FDA experts. All of our consultants are experienced in their specialized field. Unlike any other firms, Mtech has implemented the Multi-Screen Program and Internal QA department to ensure the quality of our services.
- Auditing: We perform all types GMP and GLP Audits and provide a very detailed, specific report of recommended actions, including full references to the pertinent regulations and guidance documents. We also help our clients in CSV Audits and DMF services.
- Compliance Problem Resolution: We have helped organizations facing compliance problems with FDA. We have earned a solid reputation for delivering high-quality insight and recommendations to resolve those challenges.
- Quality Systems: We will create, review, implement or improve any Quality Systems, including all those for QA, Manufacturing, Laboratories, and support groups.
- Computer System Validation: We can write the SOPs, Master Plans, and protocols required to make sure your systems are fully validated and compliant with 21 CFR Part 11 Electronic Records, Electronic Signatures.
- Equipment Qualification: We will write the qualification protocols on all major pharmaceutical equipment or review your current program to ensure it is current and compliant
- Process Validation: We will set up a process validation program that will pass inspector scrutiny, everything from writing the SOPs and Master Plans to writing and executing the protocols and summarizing the data into usable reports.
- Facility Monitoring: We will review your current Facility Monitoring program to ensure it is robust enough to pass inspection. We will help you analyze locations that show frequent excursions for how to correct the situation. We will also analyze data, create trend reports, and write validation protocols.
- Utility Monitoring: We will review your Monitoring programs for water, steam, and plant supplied gases and help you setup a more robust program that will pass inspection. We will help you analyze use points that have had frequent excursions for how to correct the situation.