Working closely together with you, we will be able to anticipate technical and regulatory issues and help you mitigate the risks. This should enable you take your project through development and submission to commercialisation – without detours.
Having the CMC manager as the point of contact to regulatory bodies, as well as communicating with other external parties (e.g. CMOs) can make your life much easier. There are clear advantages to having a dedicated CMC manager supporting your development project, such as:
Having guidance from preclinical and clinical development to the commercial stage.
Securing qualified management of project on a daily or weekly basis.
Assuring deliverables together with technical experts and other stakeholders.
Having input to timelines to ensure that project deadlines are met.
Our consultants can be part of your organisation and take over as the primary point of contact for a specific product, reducing your workload and helping you plan resources efficiently with potential to both expand and contract.
Arex Advisor can support regulatory CMC activities and submissions in all drug product phases.
Here are specific examples of work we do:
– Manage and track technical documentation
– Support product launches
– Coordinate CMC/ Tech Ops teams
– Regulatory impact assessments of CMC change controls
– Elemental impurity assessments to fulfill ICH Q3D requirements
CMC documentation management
Formulation development and manufacturing advice
CMC strategies
Technical advice and support
Erik Hedner
Arex Advisor AB
Contact us
Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.