Regulatory and Quality |

Overview

Innoventz provides Regulatory Affairs Consulting and Quality Systems Services by combining our in-house expertise with our network of consultants. With this combined expertise, we are able to provide guidance, formulate clinical and regulatory strategies, and implement these strategies at each phase of the product development life cycle. Our sensitivity to timelines, coupled with our strong desire to provide personalized attention and cost effective methods to our customers, elevates us above our competition through high customer satisfaction.

We are able to provide our customers with the following services:

Development of regulatory plans, submissions, strategies and analyses from concept to approval
510(k)s
PMAs
IDEs
HDEs
International applications for clinical trials, including Investigator Brochures
Export Approval Applications
Design Dossiers and Technical Files for CE Mark
FDA Liaison and Notified Body Liaison

NCRG has strong relationships with regulatory agencies and we serve as liaison for our clients through the regulatory and clinical processes. In addition we have a strong network of industry and professional contacts with whom we have long term relationships:

Food & Drug Administration
Physician Investigators
Notified Bodies
Industry Leaders
Leading Physicians Around the World
Venture Capital Firms

Get started today by contacting Innoventz.

Call us at (626) 796-3376, email us at info@innoventz.com , or use the Request Information form.