Medical Devices

Outsourcing Quality Assurance with RMC

We have a number of highly experienced and effective Quality Assurance personnel available to help with:

  • Serving as sponsor’s Quality personnel for API and product manufacturing, control and release activities
  • Vendor, contractor and internal quality audits (see GxP Material and Service Supplier Audits)
  • Preparation and data verification of global regulatory submissions
  • Quality System design, creation and implementation and/or execution (policies and SOPs)

How are we unique?

  • We bring a systems approach to Quality operations, viewing Quality as a technical platform rather than just - reactive policing program in place to detect wrong-doing
  • Our staff are pragmatic and solutions-driven; we don't just identify issues, we help resolve them
  • We operate in teams, offering both cross-functional CMC expertise as well as back-up staff to provide knowledgeable, reliable and cost-effective QA service

Why are we effective?

  • Global Pharmaceutical industry experience from development through commercial stages
  • Experience with US, European as well as Japanese and various Asian GMPs and integrated GxP expectations
  • RMC's team of CMC professionals gives you seamless access to a wide knowledge base

Why consider QA outsourcing?

  • The ultimate approach to ensure independent quality oversight
  • Immediate access to experienced experts, with little or no learning curve required
  • Offers staffing flexibility without the expense and commitment of recruiting permanent hires
  • A way to easily expand staff capacity to address short-term surges – and just as quickly ramp down when the workload diminishes
  • Allows your internal staff to focus on core competencies or critical areas