Our regulatory affairs services leverage an approach that is designed to deliver a high quality, cost effective solution for lifecycle maintenance of established products.
Our regulatory affairs services include both pre-approval and post-approval activities ranging from the compilation, publishing, and dispatching of large regulatory dossiers to the authoring of routine product variations, annual reports and other product lifecycle maintenance tasks.
Our primary consulting services for Regulatory Affairs include:
We have the experience in providing the support needed to obtain your ISO 9001, ISO 13485, ISO/TS 16949, ISO 15189, & ISO 22000 certifications. If you are looking to market devices overseas, we can help you select a recognized Notified Body and prepare submissions for CE certification and product CE marking. We will also prepare submissions and assist in JPAL (Japan) and CFDA (China) registration.
We can help you conduct your clinical trials and assure compliance with GCP regulations.
Submissions & Filings
E.M.M.A. will take the lead in preparing your NDA, PMA, 510(k) and other FDA submissions. Are you experiencing difficulties in meeting the required FDA reporting deadlines for MDRs? We can assist with your investigations and reporting, and put the processes in place to keep you in compliance.
Executing a recall is a daunting project that can exhaust your resources. Let E.M.M.A. manage the recall process to free up your people so that your business doesn’t suffer.
E.M.M.A. will help you implement the corrective actions necessary to respond to observations and findings from FDA 483 reports, Warning Letters, Consent Decrees, ISO audits, and customer audits. Additionally, we can help you provide the appropriate written responses to these agencies.