typical regulatory projects
Our team has hundreds of years of combined experience in the industry and at the FDA. We apply the knowledge we’ve gained with rigor to regulatory projects such as:
Regulatory Strategy & Submission Prep
Clinical Evaluation Reports to MEDDEV 2.7/1 rev 4
Chemistry, Manufacturing and Controls
Regulatory Agency Interactions
Our Services Are Unique By Industry
Our team helps you navigate the maze of global regulations and standards that products and quality systems must meet in order to satisfy regulatory requirements. The nuances between products, classifications, testing requirements and compliance standards require customized regulatory project planning for each industry.
There’s seemingly no end to the compliance requirements the medical device industry must meet. With both pre-market to post-market support, our experts can help with everything from regulatory strategies and due diligence to audits and compliance handling.
Compliance standards for pharmaceutical companies are complex — for good reason. Our regulatory experts can successfully navigate all pre-market and post-market needs, from regulatory strategies and due diligence to audits and compliance handling.