REGULATORY AFFAIRS

REGULATORY AFFAIRS

Our strategic pathways! We leverage an approach that is designed to deliver high quality, cost-effective solutions for our customers. Our focus is to accelerate the regulatory approval process for firms in the Life Sciences industry.

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 FDA compliance include:

Certifications and Registrations

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 international registrations.

Clinical Trials

We can help you conduct your clinical trials and assure compliance with GCP domestic/international regulations. We can:

Write protocols
Write informed consent forms
Oversee clinical trials and assure compliance with GCP regulations

Submissions & Filings

We 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.

Medical Device Submissions

We will prepare your device or combination product submission from the beginning to the end, including:

    • PMA (Premarket Approval)
    • 510(k) (Premarket Notification) Traditional, Special or Abbreviated
    • De Novo (Evaluation of Automatic Class III Designation)
    • HDE (Humanitarian Device Exemption)
    • Any other FDA submission
    • Technical Files (CE Mark)
    • Design Dossiers (CE Mark)
    • International Submission files

Recalls

Executing a recall is a daunting project that can exhaust your resources. Let us manage the recall process to free up your people so that your business doesn’t suffer.

We will manage your recall issue(s) from the beginning to the end, including:

    • Identification of customers,
    • Authoring of notification letters,
    • Sending out required notifications and follow ups.

We will efficiently take care of time consuming activities to allow your everyday operations to keep moving forward.