Medical Devices

Outsourcing Quality Assurance with RMC

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

Drug API and product manufacturing, control and release sponsor responsibilities
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 (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?

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

Why consider QA outsourcing?

The ultimate approach to ensure independent quality oversight
Immediate access to experienced experts, with 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
Allows your internal staff to focus on core competencies or critical areas