REGULATORY AFFAIRS, QUALITY & MANUFACTURING

Regulatory Affairs Executives

The regulatory landscape continues to evolve in response to product safety concerns, new technologies and the complex considerations of individual stakeholders, with new and expanding regulations, regulatory direction, and increased oversight. 

We work with regulatory professionals who understand how to navigate the complexities facing today’s healthcare industry.  The people we represent know what regulatory considerations are germane to making prudent strategic investment decisions and they are able to provide advice on regulatory concerns throughout each stage of a product’s life cycle.   They are able to expertly and objectively evaluate your company’s risk profile and proactively put in place strategic solutions that lead you through the various product development stages, application submissions, final product approval , and commercial regulatory requirements.  We help companies identify and acquire regulatory professionals who are able to contribute at the following levels:

· C- Suite

· Vice President

· Director 

Quality/Manufacturing/Technical Operations Executives

The heavily regulated environment in which pharmaceuticals and medical devices are produced necessitates the acquisition of executives who have an extensive track record delivering successful outcomes. The people we represent are executives who possess a pragmatic, strategic view of internal processes and quality system development, and have a deep understanding of sophisticated pharmaceutical manufacturing supply chains. They have substantial experience interacting and negotiating with FDA and other global regulatory agencies. We help you identify and employ strategic GMP experts who are able to provide tactical solutions to your significant production and compliance issues. We assist our clients by helping them identify and acquire quality professionals who are able to contribute at the following levels:

· C- Suite

· Vice President

· Director