Post-Market Compliance Support
Creating a Clear Path for Regulatory Compliance
We’ll help translate the post-market plan you created in your PMTA filing into your compliance strategy, creating the policies, infrastructure and a gameplan to manage your regulatory risk.
Bespoke post-market solutions that balance your budget and risk
Develop a plan for “what do we do when X happens” that aligns with your business and product strategy.
Through our substantial work with the FDA, both as former FDA employees and while assisting other nicotine manufacturers, we have acquired a valuable roadmap and competitive edge. This positions us to efficiently guide you towards compliance, saving you time and effort.
We offer a streamlined post-market compliance plan tailored to align perfectly with your business objectives.
Leverage our expertise to steer your regulatory strategy.
Our Approach to Compliance Following Regulatory Decisions
Whether you’re responding to a “marketing granted order”, “refuse to accept” or refuse to file” letter, or a “marketing denial order”, let us help you with our next action.
Assess what areas need to be addressed, and avoid costly duplications, that get your product to market faster.
Develop a submission strategy that leverages product data to tell a compelling story about why your product should be available to consumers.
Guide your team on the development of quality standard policies, including: compliance handling process development, adverse event reporting, marketing research studies, manufacturing deviation reporting plans, and quality control systems.
Understand what your team needs to do on an ongoing basis to remain in compliance.
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