The Gnomon Group

The Gnomon Group is a pharmaceutical and biotechnology development consulting group providing regulatory, clinical, preclinical, CMC, medical writing, and project management services for drug development companies.

We are dedicated to helping small to medium-size pharma, biotech and medical device companies navigate the complex procedures and regulations involved with the development of small molecule and biologic drugs and medical devices.

We are located within easy access of the Research Triangle Park area of North Carolina, but also serve clients nationally and internationally.

Founded in 2007 by Mike Dalton and Tom Shumaker, each with extensive pharmaceutical industry experience in both large and small companies, The Gnomon Group can help your organization:

  • Meet the US and international regulatory expectations required to initiate clinical trials
  • Prepare the necessary regulatory documentation for a successful Initial IND
  • File and maintain your IND and NDA in full eCTD-compliant format
  • Source and manage your CTM and commercial supply chain
  • Initiate, manage, analyze and report your clinical PK, safety and efficacy studies
  • Manage your safety reporting needs
  • Setup and maintain Regulatory and Due Diligence files

Through our network of expert associates, we provide assistance in all phases of product development, from pre-IND through NDA filing and approval. We specialize in helping small or virtual companies meet their product development requirements. We routinely act as a company's regulatory operations group, preparing and filing INDs as well as maintaining IND files. We also act as the regulatory contact (or US Agent) with the FDA for many of our clients.

Contact The Gnomon Group to learn how we can advance your product development activities in a timely, resource-efficient manner. We would be pleased to provide you with a confidential no-cost review of your regulatory and development needs.