Company History

RMC was founded in 2004 by Scott Rudge and Timothy Joy. Our vision was to build a different type of consultancy practice, where we offered broad solutions to clients, not just pontification. To this end, we sought to expand the company by adding cross-disciplinary experts that would span the topics typically required for the development of a new medication, medical device or diagnostic

Our approach has been adopted by a wide variety of clients, both large and small. Examples of the projects we have engaged in are:

Multiple assay, equipment, sterilization, cleaning and process validation projects
Supply chain auditing on an international level
Regulatory document authorship and review
Regulatory inspection support, particularly at contract labs and manufacturers
Comprehensive quality services, we have served as the quality unit for several start up and mid-cap companies
Cell culture and fermentation process characterization and tech transfer
Formulation development
Due diligence for a multimillion dollar investment
Construction of a new GMP facility for tissue processing
Tech transfer and process validation for a major late stage biotechnology product.

In 2006, we moved in to custom designed office/laboratories, in order to provide clients with answers to their questions, backed by data, rather than just the questions. Since this time, we have executed a number of projects, including:

Creating and purifying authentic impurity standards
Developing capture chromatography processes
Reformulating a cytotoxic molecule for oral delivery using nano-crystal technology
Developing UF/DF processes for removal of small molecules, particularly surfactants
Small scale hand filling of toxicology supplies
Blinded testing of a diagnostic kit as validation for an FDA submission
Developing a variety of analytical chromatography methods for small molecules, proteins and oligonucleotides

In 2011, we are moving into expanded facilities and plan to offer GMP packaging and labeling services for clinical trial materials (CTM) for Toxicology, Phase I and Phase II testing.