Regulatory Affairs

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)
APAC Requirements
South America
Canada

Regulatory Strategy

We help you to understand both the regulatory landscape and relevant precedents, which are continually changing and evolving.  We will help you build a crucial framework for the overall development plan and aid in determining the most efficient path to market for your product.

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.

ISO 9001
ISO 13485
ISO 14001
ISO 14971
ISO 14155
Six Sigma
We also partner with Pilgrim Quality Solutions to provide the best customizable QMS automation.