BioNReg CMC Consulting
Regulatory Affairs Expert in Chemistry, Manufacturing and Control (CMC)
of Biological Products
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If you are facing CMC scientific & regulatory challenges and questions, BioNReg CMC Consulting can help you to overcome these !
What are the specifications or stability programs to apply during phase 1 to phase 3 development ?
Need extra resource for Module 3 authoring and preparation of a new marketing application?
Missing experience in management of change controls for your registered products ?
Need management resource for running your CMC development programs and interact with Technical Teams ?
How to reach out to Authorities when CMC issues arise?
Regulatory challenges can be diverse and numerous during the life of a biological product, and Pharma & Biotech can face lots of CMC questions and needs:
Collaboration & Team spirit,
Engagement & Project-oriented,
Flexibility & Efficiency
Provision of scientific and strategy regulatory advice and operational support adapted to each Company specific needs:
Helping biopharmaceutical and biotech companies to meet their CMC challenges during product development, licensing and post-approval
Our Mission
Our Values
Scientific and CMC regulatory advice to help optimizing CMC and regulatory strategies during the entire product development, licensing and post-approval phases
Authoring and review of CMC dossiers – from clinical trial, to new marketing application to post approval variations and authorities briefing documents.
Management support, including interim management, project management & connection and support to Technical Teams, issue & risk management
Training/coaching of staff and/or Managers
We are quite flexible in how we deliver our work: it can be either at your site, or on a remote basis or as a combination of both, as best suitable for the mission
