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Is your company facing stringent state, federal, and global regulatory compliance requirements? Count on Tim Rosa Associates for expert guidance. We have the insight and experience to help pharmaceutical, biotechnology, life sciences, financial services and technology companies satisfy the compliance documentation requirements of the U.S. Food and Drug Administration (FDA), other global regulatory agencies in Canada, Europe, and Japan, and the U.S. Securities and Exchange Commission (SEC). Our compliance specialists work with you to understand the regulations in the context of your business—the people, process, computer software and hardware. Then, we develop a validation master plan and get buy-in from all key stakeholders. Working in collaboration with Tim Rosa Associates leverages the domain expertise of your in-house personnel and the knowledge and experience of our regulatory and medical writers. We'll create templates and documentation that meet the regulatory requirements, freeing up your staff to focus on their core tasks to keep your business humming. By partnering with Tim Rosa Associates, you'll enjoy peace of mind knowing that you have successfully demonstrated full compliance with all applicable regulations without taking key resources away from critical projects. We can help develop documentation to fulfill obligations stemming from regulations like these: 21 CFR Part 11To comply with FDA regulations on electronic records and electronic signatures, you need well-researched and well-executed validation documentation. We have proven expertise developing the full suite of documents required by 21 CFR Part 11 for both emerging companies and industry leaders. You'll be able to demonstrate to regulatory agencies that you have a well-planned systems development life cycle and are in full control of the product development process. Sarbanes-Oxley Act To help you demonstrate that the financial information your investors receive is complete and truthful as mandated by the Sarbanes-Oxley Act—a response from Congress following the corporate scandals of 2002—we can develop well-reasoned materials that present your position in compelling terms. We have a winning track record in this emerging and critical area and can help your company satisfy these demanding compliance requirements. ISO 9001:2000 There are 209 "shall" requirements in the ISO 9001:2000 document. Once you obtain buy-in from executive management for an ISO 9001:2000 implementation, your management team needs a clear understanding of the company's strategic plan and how it relates to the ISO 9001:2000 documentation requirements. The strategic plan should define quality for the company so you can determine meaningful measurements. At Tim Rosa Associates, documentation is our business. We know the ISO 9001:2000 requirements and can help you develop policies, processes, and standards to achieve ISO 9001:2000 certification. |
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