Committed to serving your regulatory needs
Naviga LLC is a SWOB (Small Woman Owned Business) dedicated to guiding you through the rapidly changing regulatory landscape. Our consultants will get to know you, your products, and your market so we can tailor solutions to your needs. Contact us to see how we can help you.
Regulatory Solutions
From startups just beginning to explore your regulatory options and develop a comprehensive strategy, to companies with existing portfolios whose RA/QA teams need help with specific projects and filings, Naviga will provide expert help.
Regulatory Strategy
Your business and go-to-market strategy should be informed by sound regulatory strategy. We research options and develop strategies.
Technical writing and assembling submissions
Yes, we can help your team with the “heavy lifting” of writing technical documentation.
Technical review and gap analysis
Our scientists will review your data and documentation, identify gaps that could be problematic, and suggest solutions.
QMS Audits
Our trained auditors will examine your QMS and your vendors and subs for compliance with applicable regulations and guidances.
Inspection Prep
FDA, Notified Bodies, ISO 13485, ISO 17025… we will make sure your documentation and your employees are ready.
Building Your QMS
Whether you are a medical device or pharma company, a CLIA lab, or a regulated analytical chemistry lab, we will build your QMS.
Check out our Regulatory Review blog.
We regularly post articles on topics of interest to RA and QA professionals.
Naviga Regulatory Consulting 