CMC Healthcheck

RML Pharma Consulting, in conjunction with IEXA100 now offers a new CMC Healthcheck service.

It is ideal for companies seeking opportunities to in-license or out-license products as part of their business growth and portfolio development. An assessment of the readiness and quality of the CMC package is needed to identify potential development issues both on and off the critical path which could impact the delivery and value of a project.

Unforeseen problems can be deal-breakers but can now be avoided by using a CMC Healthcheck.

A Healthcheck is all the more critical for companies that run a virtual development model, as many disparate groups may have been involved during development and there may have been a lack of continuity due to budgetary constraints.

The CMC Healthcheck is offered at three fixed-fee levels (bronze, silver or gold) tailored to meet any budget and to suit your specific requirements.
 
Benefits include:
• technical review of synthetic process analytical methods and data to support CMC
  packages (regulatory submissions or in-licensing/out-licensing activities)
• synthetic route evaluation including cost-of-goods calculations and highlighting of
  key risks/issues moving forwards
• genotoxic impurities assessment
• analytical methods, validation and specifications
• formulation development/manufacture assessed (gold CMC Healthcheck only)
• key issues identified and reported
• issue resolution strategies supplied

Contact now for more details and an initial obligation-free chat.