Regulatory Compliance Associates® clients play a critical role in the life science industry — from pharmacies and pharmaceutical companies to healthcare systems and consumer products. We’ve helped the smallest of biologic startups to the most reputable medical device manufacturers in the world. Clients reach out for expert counsel on various regulatory compliance topics ranging from quality systems to regulatory strategy or assistance in new product development.
Sometimes we’re called in as a neutral third party for the next audit. Often we help companies commercialize and expand distribution to new countries through the regulatory submission and compliance process. Regulatory Compliance Associates® can deliver results for your team that generate revenue, inspire confidence and increase sustainable compliance.
Client Solutions
Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:
- Companies new to FDA, Health Canada or EU regulations and regulatory compliance
- Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
- Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
- Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans