Regulatory Affairs

BioGenesis Health Cluster designs a comprehensive solution for Complying with FDAcGMP, GLP, and GCP regulations which is a complex and daily concern for biotechnology, pharmaceutical and medical device companies, whether virtual organizations, operating companies, or contract manufacturers. Our combined experience in all of these areas to help our clients increase compliance, accelerate timelines, and shorten their to-do lists.

BioGenesis Health Cluster Serves Biotechnology, Pharmaceutical, Medical Device and Diagnostic Companies. We understand the unique challenges associated with developing drugs, biologics, devices, diagnostics, and combination products.

BioGenesis Health Cluster helps maximize limited resources by providing the right kind of support only when needed.Our experienced industry professionals can also step in during times of unexpected demand or to manage one-time events as well as make a quick substitution for an employee who is out for a lengthy period of time or leaves unexpectedly.