About Us

At RMC, we integrate our team with your team to solve problems and advance programs. Collectively, the members of our staff have a remarkably wide and deep knowledge base across the medical products fields—we can assemble the right team of functional experts for any project, large or small.

We are creative in a regulated environment. We understand the intent behind the regulations, we understand the science behind the products and we can confidently build an appropriate strategy or execute a program to address clients’ needs.

We bring a nimble and stage-appropriate approach to development. This ensures that activities are streamlined and resources conserved in the early stages while building a solid foundation for the greater complexity of later development stages.

We are practical and science-driven. Our experienced team helps you avoid common development pitfalls. Ultimately we rely on good science to make good decisions.

Our “Different” Approach

What makes our service different from other consulting groups in this space?

  • We won’t just take the oldest path available. While we’re prudent in our approach, we will research new techniques and find an approach based on best practices developed from a cross-functional view of our business and an understanding of your technology and the intent of the regulations
  • We work constantly to identify and evaluate new technologies in business, analytics and processes to educate ourselves and benefit our clients. Among the tools we use are decision analysis, process modeling and statistics software, subscriptions to leading edge business journals and on-line access to thousands of technical and business resources, and web enabled tools for intra-team communication so that we can apply all of our skills to a client’s problem quickly from around the globe.
  • We bring a systems approach to Quality, viewing it as a technical program, rather than a reactive policing program in place to detect wrong-doing. Our quality systems are designed to be self- checking and to place responsibility and capability with the executor of a given task to perform it with high skill and reproducibility.
  • We bring a quality approach to technology, applying statistics to the design of the experiment, and to the analysis of the results. We look for gaps and apply quantitative sensitivity analysis to estimate if the gap has a physical chance to affect the experimental outcome. We design early development work so the quality is built in, so the client can leverage it for product registration, rather than repeating the work at a later date under more quality controls, and we do it without adding onerous requirements to the scientist’s work.

We hope this brief introduction gives you some insight into how we conduct our business, and what makes our team a great resource for your team. We are truly Responsive, Measured and Creative®!

RMC Pharma 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 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, RMC significantly expanded the depth of our expert services team. We added a new site serving the RTP region in North Carolina, and bolstered our training products and services program. RMC also launched a comprehensive custom-video production service; focused on creating pharmaceutical training and marketing videos.

From 2018 through 2021, RMC continued to bolster its industry-leading expert Bolt-on CMC® services team with the addition of multiple experienced and emerging pharmaceutical and biotech professionals. These additions further expanded the expertise of the RMC team in small molecule, analytical development, as well as general CMC expertise including Advance Therapy Medicinal Product (ATMP) areas, biologics, gene and cell therapy, and mRNA. With personnel located in several geographical locations, including its central operations in Colorado and satellite personnel in North Carolina (RTP), Pennsylvania and Washington (Seattle), the RMC team supports projects around the globe.