FDA Submissions & Other Regulatory Services
Experience drives successful FDA submission processes. With both industry leading and direct FDA experience, MCRA’s regulatory consulting team has the experience and confidence in navigating the FDA submission process. MCRA can lead projects or work with internal teams to prepare and submit documentation to affectively address regulatory concerns and minimize additional deficiencies. Today, MCRA is the leading advisor for neuro-musculoskeletal PMAs. This know-how is increasingly important as regulatory approval processes become more stringent. MCRA regulatory consulting team works with its clients to review, prepare, and submit the required documents to effectively address FDA regulatory concerns and minimize additional questions.
Additionally, MCRA performs an array of other services, including, but not limited to, international regulatory approvals, new product acquisitions and transfer of ownership, adverse event reporting, site registrations, device listing, & acting as US agent for foreign companies. MCRA’s FDA submission and annual update experience includes: 510(K), IDE, PMA, IND, BLA, & De Novo. With any submission process, MCRA’s distinguishing factor is that our integrated services provide a full scope assessment that enables our regulatory consulting team to quickly and accurately guide our clients through the most challenging submissions.
To speak with a regulatory consultant, please call 202.552.5800