Regulatory Affairs

Our Regulatory Affairs consultants are available whether you need someone just-this-once to substitute for an employee who is unavailable, or you are a start up and need regulatory strategy in conjunction with your overall business objectives. We will guide you through regulatory planning, project management, strategy execution, and the regulatory agency (FDA, EMEA, etc.) meeting and submission process, as our consultants are experienced with drugs, biologics, biosimilars, biobetter, medical devices, delivery devices, diagnostics, and combination products.

Our drug and biologics experts will assist you in navigating your regulatory pathway through the pre-IND, IND (including CTD format), and NDA/ BLA
505(b)(2) submission process whether for originator drug or biologic, or generic, biosimilar, or biobetter. We can also manage your CDER or CBER correspondence and meetings, and prepare amendments or other revisions.

Our Medical Device experts will assist you in preparation and submission of 510(k) Premarket Notifications, Investigational Device Exemption Applications (IDEs), Premarket Approval Applications (PMAs), and 513(g) Requests for Classification. We can also manage your CDRH correspondence and meetings.