Ensuring your company complies with all of the regulations and laws pertaining to your business. Working with federal, state and local regulatory agencies and personnel on specific issues that affect your business. Advising your company on the regulatory strategy and climate that may affect your proposed business plan. Global Regulatory Submissions, including but not limited to:
|US (FDA, ITAR, Joint Commission)|
|Europe (CE Mark)|
We can facilitate assembly of a total picture of the scope of nonclinical, technical and clinical testing that will be required for registration.
We make sure you can fully understand the expectations, carefully evaluate potential hurdles, and create a plan to proactively address them early in development.
Quality System Management
From start-up to revamping your current QSM, we can help you become compliant, increase quality, become more efficient, etc.
|We also partner with Pilgrim Quality Solutions to provide the best customizable QMS automation.|