HOW CAN WE HELP?
Startup and small biotech
With our extensive experience in driving drugs from early developments to the markets, we can help small and micro-virtual companies in transforming the idea of a drug into its industrial production.
Mid-size and big groups
Our external support is also convenient for structured mid-size and big groups for specific tasks with expert readily hands-on and independent, when internal FTE dedicated resources are missing or unavailable. For example, a technical transfer or a local CDMO supervision are usually managed with 1-2 days per week.
Initial due diligence of external providers
Why appointing who has never managed a development project, for the first audit of your new CDMOs? Who is expert both in cGMP and in CDMOs management can highlight the non-GMP risks which may affect the development and the future interactions in the production of your drug.
Due diligence of new projects
In few days we can provide a CMC gap analysis when licensing in a new project, or reviewing an investigational/registration dossier.
Interaction with regulatory authorities
We can promptly support in answering to the information requests coming from the authorities focusing on science, but with full knowledge also of GMP and regulatory needs.