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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 an in-house laboratory set up to accommodate formulation development for both small molecules and biologicals; we can also manage and coordinate activities performed in other labs. We have several experienced development scientists ready to help with:

  • Solubility and/or suspension studies
  • Forced degradation studies
  • Product characterization
  • Excipient selection, optimization and compatibility studies
  • Vial, cartridge, and pre-filled syringe final product presentations
  • Aseptically processed and terminally sterilized injectable dosage forms
  • Liquid, lyophilized and dry-powder fill/finish
  • Solid dosage final product presentations
  • Protein and monoclonal antibody formulations

RMC’s capabilities

  • As needed, we can bring together a complete product development team-- including functional area experts in process, formulation and analytical development; manufacturing; quality control; and quality assurance
  • In-house analytical techniques include HPLC, particle size distribution (dynamic light scattering), zeta potential determination, pH measurement, loss on drying, UV/VIS spectrophotometry and moisture content

Why outsource formulation development?

  • Partner with technology experts who are also versed in global regulatory requirements and expectations
  • Gain immediate access to experienced staff, with no learning curve required
  • Obtain high quality development and support, without the expense of setting up and maintaining a lab
  • If you are seeking a permanent hire, RMC provides you with time to find that perfect fit while moving forward with strategy, planning and start-up activities
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