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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