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 have regularly expanded the company by adding cross-disciplinary experts that would span the topics typically required for the development of a new therapeutic, medical device or diagnostic product.
Our approach has been adopted by a wide variety of clients, both large and small. Examples of just a few of the projects we have engaged in are:
- Multiple assay, equipment, sterilization, cleaning and process validation projects
- Complete supply chain auditing at the global level
- Regulatory document authorship and review
- Regulatory inspection support of not only GMP contract labs and manufacturers, but also for GCP, GDP and GVP inspections
- Comprehensive quality services, where we have provided top to bottom quality unit personnel for several start up and mid-cap companies
- Cell culture and fermentation process characterization and tech transfer
- Formulation development
- Due diligence for multimillion dollar investments
- 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 into 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 (but not limited to):
- 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 expanded our facilities again to over 8000 sq.ft. to further increase our hands-on development and trouble-shooting capabilities.
For 2017, we are evaluating a potential ~4000 sq.ft. expansion to optimize RMC’s ability to provide our clients with that unique blend of expert execution and the fast, independent hand-on development/trouble-shooting data they’ve come to expect from RMC.