What is “Bolt-on” CMC?
Bolt-on CMC support provides
integrated, team-based management of Chemistry, Manufacturing
and Control activities. This
includes oversight of such areas as process, analytical and
formulation development; quality control and quality assurance;
GLP/GMP manufacturing of API and drug product; and packaging/
distribution. Our multi-functional team of experts represents
a drug sponsor in coordinating CMC projects across all
development stages, from pre-IND to post-approval. We
don’t simply make recommendations; we actively work to
make your project a success.
Why hiring contract manufacturing and testing services
is not enough
- Individual CMC contract service organizations only
provide pieces of the package
- Information from a range of sources must be smoothly
synthesized into the CMC section of a regulatory
submission
- CMC activities need to be integrated into the broader
project plan, coordinated with other departments
such as clinical and regulatory
- Requirements and priorities change over the product
lifecycle—RMC’s integrated CMC project management
ensures appropriate staging of activities as well
as incorporation of new information into ongoing
decisions
- Sponsor must retain ultimate responsibility for the
quality of the product and program
RMC’s team advantage
- Ready-made CMC teams bring together cohesive, multi-functional
technical expertise with integrated project management
- RMC’s team of CMC professionals gives you easy access
to a wide and deep knowledge base
- Efficiency is gained by using RMC’s document and
project management templates
- RMC’s team operates under a single quality management
system/philosophy
- Team composition can be tailored to fit each particular
project and development stage
How a drug developer benefits from bolt-on CMC
- Structure the organization rapidly and flexibly by
“bolting on” a single interlocking CMC department
to oversee and integrate all related activities
- Gain comprehensive coordination of activities performed
at all CMC contract services providers
- Develop consistent, stage-appropriate Quality Systems
within the company
- Advance early-phase products to a more value-added
stage by building and executing a comprehensive
CMC strategy
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