Regulatory Support
When should I engage a Regulatory Consultant?
Even if the device is in early development, a regulatory consultant can help you see how different design forks will lead to significantly different regulatory pathways.
How much does a Regulatory Consultant Cost?
At Apsis CG we will always give you a fixed-price proposal. Whether you just need a regulatory strategy or help with a full submission.
Am I ready to submit my marketing submission to the FDA?
Before you submit Apsis CG recommends a technical gap analysis of your files to ensure you're ready and save time and money
Quality Support
How much of a Quality Management System do I need?
Having an oversized QMS will slow your operations and make you vulnerable to audits . We will custom tailor your QMS for your organization.
How much does a full QMS cost?
We have flexible options. From DIY templates with advisory support to full customization.
We don't have a need for a full-time Quality Manager/ Engineer. What options are there?
A Fractional Quality Manager can provide you with expert-level support when you need it, without needing a FTE.
Auditing
We recently had a negative FDA audit. Can you help?
We can help you with any 483s, Warning Letters or even untitled letters. We have a thorough understanding on how to respond to FDA queries and can help.
Do you do internal audits?
Yes, we can be your outsourced internal auditors.
Do you do certification audits?
While we don't do certification audits, we can help you get ready for your 13485 or FDA audit. Conducting a mock audit will help you make sure your organization is ready.