Frequently Asked Questions
Non-Clinical Drug Development & Regulatory Consulting
- What is the regulatory framework for developing an autologous gene therapy product?
- When is the right time to ask for regulatory/scientific advice?
- Which authority to select for a first scientific advice? FDA, EMA or European National Authorities first?
- A non-clinical program without animal studies – is this possible?
- Where to place pivotal GLP studies? What if there is no ideal CRO?
- What to do with unexpected toxicological findings?
- Can immunocompromised mice be used in GLP toxicology studies?
- How to address the genotoxic risk of gene-edited therapeutics?
- How to integrate a development plan into a proper project plan and deliver the agreed outcomes according to the scope, timescale and quality of the program?
- How to manage risks, dependencies and critical path activities?
- How to provide communications, reports and progress updates of the project?
Scientific / Regulatory Writing
- Does the research report comply with regulatory requirements?
- Drafting Briefing Dossiers for Scientific Advice – how to make regulators comfortable?
- How to structure a documentation system to facilitate CTD submission later on?