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Quality Services

Compliance Services

Process and Product Development

Analytical Development,
QC and Stability

Biosafety Services

Protein and mAb Development

In-House Laboratory Services

Validation and Calibration

Project Management

Facility Service

Strategic Planning

Due Diligence

Useful Resource Links

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RMC has a number of highly experienced and effective analytical staff available to help with:

  • Oversight, management or execution of analytical method development, validation and transfer
  • Specification development
  • Stability program development and oversight, as well as statistical trending of stability data
  • Product characterization
  • Reference standard program development
  • Sample management and chain of custody processes
  • Investigation of deviations, method failures and out-of-specification processes
  • Analytical laboratory set-up including equipment specification, SOP development, training, etc.
  • Development, oversight and review of comparability protocols and assessments
  • Writing and review of CMC sections for global regulatory submissions
  • Comprehensive and strategic coordination of all analytical and bioanalytical activities at pharmaceutical and contract laboratories

How are we uniquely effective?

  • We are creative, pragmatic and solutions-driven
  • We don’t just identify issues, we help to resolve them through direct participation, with accountability for results
  • Our analytical professionals have extensive pharmaceutical industry experience from discovery through commercial stages
  • RMC’s team approach allows potential for including other CMC staff, such as QA, process and formulations development, process engineering and manufacturing technical experts

Why consider Analytical/QC and Stability outsourcing?

  • We have an in-house laboratory set up to accommodate process, analytical and formulation development for both small molecules and biologicals; we can also work with other contract labs
  • RMC gives you technology experts who understand current analytical methodologies as well as global regulatory requirements and expectations
  • Immediate access to experienced experts, with no learning curve required
  • 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 other core competencies or critical areas
 
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